FDA’s data, copied as published
Every count, rank and description is copied from FDA’s FY2025 Inspection Observations spreadsheet, Drugs sheet. Nothing is estimated or rewritten.
FDA Form 483 observations · FY2025 drug data
The Form 483 citations most often issued to drug manufacturers in FY2025.
Ranked from FDA’s own published data for inspections ending October 1, 2024 to September 30, 2025. Filter by decision area and open any citation to read FDA’s wording. Source: FDA Inspection Observations.
The counts cover Form 483s generated in FDA’s system. FDA notes that some 483s were prepared manually and are not in this data.
713drug Form 483s issued from FDA’s system
316drug citation entries in FDA’s data
243#1: 21 CFR 211.22(d)
236citations under 21 CFR 211.192, across 5 entries
A citation entry is one FDA citation wording. One regulation can have several entries, so the same 21 CFR section can appear more than once in the ranking.
Ask about these citations
Answers come only from FDA’s FY2025 table on this page. Counts, rankings and FDA’s wording. No advice, no interpretation of a regulation, and no prediction of what FDA will do. Do not enter confidential details.
Tap any citation to open it. Each row expands to show FDA’s exact wording and the question it raises for your own records.
All FY2025 drug citations
Showing the top 25 of 316
1 21 CFR 211.22(d)FDA cite ID 1105 Procedures not in writing, fully followed 243Read ▾
FDA’s wording
The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →2 21 CFR 211.192FDA cite ID 2027 Investigations of discrepancies, failuresDeviations & investigations 164Read ▾
FDA’s wording
There is a failure to thoroughly review [any unexplained discrepancy] [the failure of a batch or any of its components to meet any of its specifications] whether or not the batch has been already distributed.
CW · DEVIATIONS & INVESTIGATIONS
What an investigator may ask next
“Who determined the root cause and what evidence supported the determination?”
Inspection scenario: Who Authorized the Root Cause Determination? → Test a decision like this — free assessment →See the Deviation Closure Case File, a completed record of the investigation evidence, root-cause judgment, risk, alternatives and Quality closure authority behind one deviation closure. $149
3 21 CFR 211.100(a)FDA cite ID 1361 Absence of Written Procedures 162Read ▾
FDA’s wording
Your firm failed to establish [adequate] written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →4 21 CFR 211.160(b)FDA cite ID 3603 Scientifically sound laboratory controls 121Read ▾
FDA’s wording
Laboratory controls do not include the establishment of scientifically sound and appropriate [specifications] [standards] [sampling plans] [test procedures] designed to assure that [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products] conform to appropriate standards of identity, strength, quality and purity.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →5 21 CFR 211.67(a)FDA cite ID 1213 Cleaning / Sanitizing / Maintenance 95Read ▾
FDA’s wording
Equipment and utensils are not [cleaned] [maintained] [sanitized] at appropriate intervals to prevent [malfunctions] [contamination] that would alter the safety, identity, strength, quality or purity of the drug product.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →6 21 CFR 211.68(b)FDA cite ID 1263 Computer control of master formula recordsChange control 87Read ▾
FDA’s wording
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
CW · CHANGE CONTROL
What an investigator may ask next
“Who made the regulatory impact determination for this change?”
Inspection scenario: Who Approved This Change Control? → Test a decision like this — free assessment →7 21 CFR 211.63FDA cite ID 1177 Equipment Design, Size and Location 81Read ▾
FDA’s wording
Equipment used in the manufacture, processing, packing or holding of drug products is not [of appropriate design] [of adequate size] [suitably located] to facilitate operations for its [intended use] [cleaning and maintenance].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →8 21 CFR 211.67(b)FDA cite ID 1215 Written procedures not established/followed 70Read ▾
FDA’s wording
Written procedures are not [established] [followed] for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →9 21 CFR 211.113(b)FDA cite ID 1451 Procedures for sterile drug products 68Read ▾
FDA’s wording
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not [established] [written] [followed].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →10 21 CFR 211.165(a)FDA cite ID 1883 Testing and release for distributionBatch release decisions 44Read ▾
FDA’s wording
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the [final specifications] [identity and strength of each active ingredient] prior to release.
CW · BATCH RELEASE DECISIONS
What an investigator may ask next
“Who authorized this batch release and what evidence was reviewed before the decision?”
Inspection scenario: Who Authorized This Batch Release? → Test a decision like this — free assessment →See the Batch Release Authorization Case File, a completed record of the evidence, judgment, risk, alternatives and QA release authority behind one batch-release decision. $149
11 21 CFR 211.68(a)FDA cite ID 1274 Calibration/Inspection/Checking not done 38Read ▾
FDA’s wording
Routine [calibration] [inspection] [checking] of [automatic] [mechanical] [electronic] equipment is not performed according to a written program designed to assure proper performance.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →12 21 CFR 211.113(b)FDA cite ID 1452 Validation lacking for sterile drug productsValidation 37Read ▾
FDA’s wording
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include [adequate] validation of the [aseptic] [sterilization] process.
CW · VALIDATION
What an investigator may ask next
“Who authorized the validation conclusion?”
Inspection scenario: Who Authorized the Process Validation Conclusion? → Test a decision like this — free assessment →13 21 CFR 211.110(a)FDA cite ID 3585 Control procedures to monitor and validate performanceValidation 36Read ▾
FDA’s wording
Control procedures are not established which [monitor the output] [validate the performance] of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
CW · VALIDATION
What an investigator may ask next
“Who authorized the validation conclusion?”
Inspection scenario: Who Authorized the Process Validation Conclusion? → Test a decision like this — free assessment →14 21 CFR 211.166(a)FDA cite ID 1914 Lack of written stability program 35Read ▾
FDA’s wording
There is no written testing program designed to assess the stability characteristics of drug products.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →15 21 CFR 211.42(c)(10)(iv)FDA cite ID 1434 Environmental Monitoring System 33Read ▾
FDA’s wording
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →16 21 CFR 211.192FDA cite ID 4402 Written record of investigation incompleteInvestigation follow-up & annual review 32Read ▾
FDA’s wording
Written records of investigations into [unexplained discrepancies] [the failure of a batch or any of its components to meet specifications] do not [always] include the conclusions and follow-up.
CW · INVESTIGATION FOLLOW-UP & ANNUAL REVIEW
What an investigator may ask next
“Who determined this CAPA was effective and what evidence supported that conclusion?”
Inspection scenario: Who Authorized This CAPA Closure? → CAPA effectiveness check → Test a decision like this — free assessment →See the CAPA Effectiveness Case File, a completed record of the evidence, judgment, residual risk, alternatives and authorization behind one CAPA closure. $149
17 21 CFR 211.84(d)(1)FDA cite ID 1833 Identity Testing of Each Component 30Read ▾
FDA’s wording
The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →18 21 CFR 211.25(a)FDA cite ID 1111 Training , Education , Experience overall 28Read ▾
FDA’s wording
Employees engaged in the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] required to perform their assigned functions.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →18 21 CFR 211.166(a)(3)FDA cite ID 1920 Valid stability test methods 28Read ▾
FDA’s wording
The written stability program for drug products does not include [reliable] [meaningful] [specific] test methods.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →18 21 CFR 211.22(a)FDA cite ID 9001 Lack of quality control unit 28Read ▾
FDA’s wording
There is no quality control unit.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →21 21 CFR 211.84(d)(2)FDA cite ID 4314 Reports of Analysis (Components) 26Read ▾
FDA’s wording
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without [performing at least one specific identity test on each component] [establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →22 21 CFR 211.25(a)FDA cite ID 1112 Training--operations, GMPs, written procedures 25Read ▾
FDA’s wording
Employees are not given training in [the particular operations they perform as part of their function] [current good manufacturing practices] [written procedures required by current good manufacturing practice regulations].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →23 21 CFR 211.113(a)FDA cite ID 1450 Procedures for non-sterile drug products 24Read ▾
FDA’s wording
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not [established] [written] [followed].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →23 21 CFR 211.58FDA cite ID 3565 Buildings not maintained in good state of repair 24Read ▾
FDA’s wording
Buildings used in the [manufacturing] [processing] [packing] [holding] of a drug product are not maintained in a good state of repair.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →25 21 CFR 211.100(b)FDA cite ID 1358 SOPs not followed / documentedDeviations & investigations 23Read ▾
FDA’s wording
Written production and process control procedures are not [followed in the execution of production and process control functions] [documented at the time of performance].
CW · DEVIATIONS & INVESTIGATIONS
What an investigator may ask next
“Who determined the root cause and what evidence supported the determination?”
Inspection scenario: Who Authorized the Root Cause Determination? → Test a decision like this — free assessment →See the Deviation Closure Case File, a completed record of the investigation evidence, root-cause judgment, risk, alternatives and Quality closure authority behind one deviation closure. $149
25 21 CFR 211.165(e)FDA cite ID 1890 Test methods 23Read ▾
FDA’s wording
The [accuracy] [sensitivity] [specificity] [reproducibility] of test methods have not been [established] [documented].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →25 21 CFR 211.188FDA cite ID 2009 Prepared for each batch, include complete information 23Read ▾
FDA’s wording
Batch production and control records [are not prepared for each batch of drug product produced] [do not include complete information relating to the production and control of each batch].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →25 21 CFR 211.142(b)FDA cite ID 4342 Storage under appropriate conditions 23Read ▾
FDA’s wording
Drug products are not stored under appropriate conditions of [temperature] [humidity] [light] so that their identity, strength, quality, and purity are not affected.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →29 21 CFR 211.192FDA cite ID 4576 No written record of investigationDeviations & investigations 22Read ▾
FDA’s wording
Written records are not [always] made of investigations into [unexplained discrepancies] [the failure of a batch or any of its components to meet specifications].
CW · DEVIATIONS & INVESTIGATIONS
What an investigator may ask next
“Who determined the root cause and what evidence supported the determination?”
Inspection scenario: Who Authorized the Root Cause Determination? → Test a decision like this — free assessment →See the Deviation Closure Case File, a completed record of the investigation evidence, root-cause judgment, risk, alternatives and Quality closure authority behind one deviation closure. $149
30 21 CFR 211.165(b)FDA cite ID 1885 Microbiological testing 20Read ▾
FDA’s wording
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →30 21 CFR 211.84(d)(2)FDA cite ID 3567 Component identification test 20Read ▾
FDA’s wording
Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →32 21 CFR 211.42(c)(10)(v)FDA cite ID 1435 Cleaning System 19Read ▾
FDA’s wording
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the [room] [equipment] to produce aseptic conditions.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →32 21 CFR 211.166(a)FDA cite ID 1912 Written program not followed 19Read ▾
FDA’s wording
The written stability testing program is not followed.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →34 21 CFR 211.67(b)(3)FDA cite ID 1220 Cleaning SOPs/instructions 18Read ▾
FDA’s wording
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →34 21 CFR 211.180(e)FDA cite ID 1942 Records reviewed annuallyInvestigation follow-up & annual review 18Read ▾
FDA’s wording
Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.
CW · INVESTIGATION FOLLOW-UP & ANNUAL REVIEW
What an investigator may ask next
“Who determined this CAPA was effective and what evidence supported that conclusion?”
Inspection scenario: Who Authorized This CAPA Closure? → CAPA effectiveness check → Test a decision like this — free assessment →See the CAPA Effectiveness Case File, a completed record of the evidence, judgment, residual risk, alternatives and authorization behind one CAPA closure. $149
36 21 CFR 211.160(a)FDA cite ID 1809 Following/documenting laboratory controls 17Read ▾
FDA’s wording
Established [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] are not [followed] [documented at the time of performance].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →36 21 CFR 211.84(d)(2)FDA cite ID 1843 Component written specification 17Read ▾
FDA’s wording
Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →36 21 CFR 211.84(d)(2)FDA cite ID 1844 Establish reliability of supplier's C of A 17Read ▾
FDA’s wording
Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →36 21 CFR 211.188(b)FDA cite ID 2012 Batch production and Batch Control Record Requirements 17Read ▾
FDA’s wording
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in [manufacturing] [processing] [packing] [holding].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →36 21 CFR 211.56(a)FDA cite ID 3559 Sanitation--buildings not clean, free of infestation 17Read ▾
FDA’s wording
Buildings used in the manufacture, processing, packing or holding of drug products are not [maintained in a clean and sanitary condition] [free of infestation by rodents, birds insects, and other vermin].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →36 21 CFR 211.180(e)(2)FDA cite ID 4391 Items to cover on annual reviewsInvestigation follow-up & annual review 17Read ▾
FDA’s wording
Written procedures are not [established] [followed] for evaluations done at least annually and including provisions for a review of [complaints] [recalls] [returned or salvaged drug products] [investigations conducted for each drug product].
CW · INVESTIGATION FOLLOW-UP & ANNUAL REVIEW
What an investigator may ask next
“Who determined this CAPA was effective and what evidence supported that conclusion?”
Inspection scenario: Who Authorized This CAPA Closure? → CAPA effectiveness check → Test a decision like this — free assessment →See the CAPA Effectiveness Case File, a completed record of the evidence, judgment, residual risk, alternatives and authorization behind one CAPA closure. $149
42 21 CFR 211.198(a)FDA cite ID 2419 Complaint Handling Procedure 16Read ▾
FDA’s wording
Procedures describing the handling of written and oral complaints related to drug products are [not written or followed] [deficiently written or followed].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →42 21 CFR 211.170(b)FDA cite ID 3632 Annual visual exams of drug products 16Read ▾
FDA’s wording
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →44 21 CFR 211.180(e)(1)FDA cite ID 1943 Review of representative number of batchesInvestigation follow-up & annual review 15Read ▾
FDA’s wording
Written procedures are not [established] [followed] for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
CW · INVESTIGATION FOLLOW-UP & ANNUAL REVIEW
What an investigator may ask next
“Who determined this CAPA was effective and what evidence supported that conclusion?”
Inspection scenario: Who Authorized This CAPA Closure? → CAPA effectiveness check → Test a decision like this — free assessment →See the CAPA Effectiveness Case File, a completed record of the evidence, judgment, residual risk, alternatives and authorization behind one CAPA closure. $149
45 21 CFR 211.25(a)FDA cite ID 1133 GMP Training Frequency 14Read ▾
FDA’s wording
GMP training is not conducted [on a continuing basis] [with sufficient frequency] to assure that employees remain familiar with CGMP requirements applicable to them.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →45 21 CFR 211.194(a)FDA cite ID 2031 Complete test data included in records 14Read ▾
FDA’s wording
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →47 21 CFR 211.22(c)FDA cite ID 1098 Approve or reject procedures or specs 13Read ▾
FDA’s wording
The quality control unit lacks responsibility to [approve] [reject] all procedures or specifications impacting on the [identity] [strength] [quality] [purity] of drug products.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →47 21 CFR 211.42(a)FDA cite ID 1169 Buildings of Suitable Size, Construction, Location 13Read ▾
FDA’s wording
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable [size] [construction] [location] to facilitate cleaning, maintenance, and proper operations.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →47 21 CFR 212.20(e)FDA cite ID 17764 Written QA procedures established, followed 13Read ▾
FDA’s wording
You did not [establish] [follow] written quality assurance procedures.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →50 21 CFR 211.137(a)FDA cite ID 1767 Expiration date lacking 12Read ▾
FDA’s wording
Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →50 21 CFR 314.80(b)FDA cite ID 6730 Failure to develop written procedures 12Read ▾
FDA’s wording
Written procedures have not been developed for the [surveillance] [receipt] [evaluation] [reporting to FDA] of post marketing adverse drug experiences.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →52 21 CFR 211.22(a)FDA cite ID 1033 Authority lacking to review records, investigate errorsBatch release decisions 11Read ▾
FDA’s wording
The quality control unit lacks authority to [review production records to assure that no errors have occurred] [fully investigate errors that have occurred].
CW · BATCH RELEASE DECISIONS
What an investigator may ask next
“Who authorized this batch release and what evidence was reviewed before the decision?”
Inspection scenario: Who Authorized This Batch Release? → Test a decision like this — free assessment →See the Batch Release Authorization Case File, a completed record of the evidence, judgment, risk, alternatives and QA release authority behind one batch-release decision. $149
52 21 CFR 211.84(d)(1)FDA cite ID 1842 Component identity verification 11Read ▾
FDA’s wording
Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →52 21 CFR 211.182FDA cite ID 1975 Written records kept in individual logs 11Read ▾
FDA’s wording
Written records of major equipment [cleaning] [maintenance] [use] are not included in individual equipment logs.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →52 21 CFR 211.110(a)FDA cite ID 3583 Written in-process control procedures 11Read ▾
FDA’s wording
Written procedures are not [established] [followed] that describe the [in-process controls] [tests] [examinations] to be conducted on appropriate samples of in-process materials of each batch.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →56 21 CFR 211.68(b)FDA cite ID 1270 input/output verification 10Read ▾
FDA’s wording
Input to and output from [the computer] [related systems of formulas] [records or data] are not checked for accuracy.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →56 21 CFR 211.125(a)FDA cite ID 1540 Strict control not exercised over labeling issued 10Read ▾
FDA’s wording
Strict control is not exercised over labeling issued for use in drug product labeling operations.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →56 21 CFR 211.166(b)FDA cite ID 1926 Adequate number of batches on stability 10Read ▾
FDA’s wording
An adequate number of batches of each drug product are not tested [nor are records of such data maintained] to determine an appropriate expiration date.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →56 21 CFR 211.194(a)(4)FDA cite ID 2401 Complete Test Data 10Read ▾
FDA’s wording
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →56 21 CFR 211.46(b)FDA cite ID 3547 Equipment for Environmental Control 10Read ▾
FDA’s wording
Equipment for adequate control over [air pressure] [micro-organisms] [dust] [humidity] [temperature] is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →56 21 CFR 211.84(d)(2)FDA cite ID 4315 Testing Each Component for Conformity with Specs 10Read ▾
FDA’s wording
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →56 21 CFR 212.50FDA cite ID 17812 Adequate controls (general) 10Read ▾
FDA’s wording
Your firm lacks adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality and purity.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →63 21 CFR 211.103FDA cite ID 1395 Actual vs. theoretical yields not determined 9Read ▾
FDA’s wording
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of [manufacturing] [processing] [packaging] [holding] of the drug product.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →63 21 CFR 211.192FDA cite ID 2026 Quality control unit review of recordsBatch release decisions 9Read ▾
FDA’s wording
Drug product production and control records, are not [reviewed] [approved] by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
CW · BATCH RELEASE DECISIONS
What an investigator may ask next
“Who authorized this batch release and what evidence was reviewed before the decision?”
Inspection scenario: Who Authorized This Batch Release? → Test a decision like this — free assessment →See the Batch Release Authorization Case File, a completed record of the evidence, judgment, risk, alternatives and QA release authority behind one batch-release decision. $149
63 21 CFR 211.192FDA cite ID 2028 Extent of discrepancy, failure investigationsDeviations & investigations 9Read ▾
FDA’s wording
Investigations of [an unexplained discrepancy] [a failure of a batch or any of its components to meet any of its specifications] did not extend to [other batches of the same drug product] [other drug products that may have been associated with the specific failure or discrepancy].
CW · DEVIATIONS & INVESTIGATIONS
What an investigator may ask next
“Who determined the root cause and what evidence supported the determination?”
Inspection scenario: Who Authorized the Root Cause Determination? → Test a decision like this — free assessment →See the Deviation Closure Case File, a completed record of the investigation evidence, root-cause judgment, risk, alternatives and Quality closure authority behind one deviation closure. $149
63 21 CFR 211.100(b)FDA cite ID 3572 Procedure Deviations Recorded and JustifiedDeviations & investigations 9Read ▾
FDA’s wording
Deviations from written production and process control procedures are not [recorded] [justified].
CW · DEVIATIONS & INVESTIGATIONS
What an investigator may ask next
“Who determined the root cause and what evidence supported the determination?”
Inspection scenario: Who Authorized the Root Cause Determination? → Test a decision like this — free assessment →See the Deviation Closure Case File, a completed record of the investigation evidence, root-cause judgment, risk, alternatives and Quality closure authority behind one deviation closure. $149
63 21 CFR 211.194(a)(8)FDA cite ID 4413 Second person sign off 9Read ▾
FDA’s wording
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for [accuracy] [completeness] [compliance with established standards].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →63 21 CFR 212.30(a)FDA cite ID 21376 Orderly handling, prevention of mix-ups, prevention of contamination 9Read ▾
FDA’s wording
Your facilities are not adequate to ensure [the orderly handling of materials and equipment] [the prevention of mix-ups] [the prevention of contamination of equipment or product by substances, personnel, or environmental conditions] that could reasonably be expected to have an adverse effect on product quality.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →63 FDCA 582(b)(4)FDA cite ID 22921 Systems in place to comply with verification requirements 9Read ▾
FDA’s wording
Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →70 21 CFR 211.22(a)FDA cite ID 1049 Approve or reject components, productsBatch release decisions 8Read ▾
FDA’s wording
The quality control unit lacks the responsibility and authority to [approve] [reject] all [components] [drug product containers] [closures] [in process materials] [packaging material] [labeling] [drug products].
CW · BATCH RELEASE DECISIONS
What an investigator may ask next
“Who authorized this batch release and what evidence was reviewed before the decision?”
Inspection scenario: Who Authorized This Batch Release? → Test a decision like this — free assessment →See the Batch Release Authorization Case File, a completed record of the evidence, judgment, risk, alternatives and QA release authority behind one batch-release decision. $149
70 21 CFR 211.25(c)FDA cite ID 1136 Inadequate number of personnel 8Read ▾
FDA’s wording
The number of qualified personnel is inadequate to [perform] [supervise] the [manufacture] [processing] [packing] [holding] of each drug product.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →70 21 CFR 211.84(b)FDA cite ID 1802 Representative Samples 8Read ▾
FDA’s wording
Representative samples are not taken of each shipment of each lot of [components] [drug product containers] [closures] for testing or examination.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →70 21 CFR 211.160(a)FDA cite ID 1810 Lab controls established, including changes 8Read ▾
FDA’s wording
The establishment of [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] including any changes thereto, are not [drafted by the appropriate organizational unit] [reviewed and approved by the quality control unit].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →70 21 CFR 211.166(a)(4)FDA cite ID 1922 Testing in same container - closure system 8Read ▾
FDA’s wording
The written stability program does not assure testing of the drug product in the same container-closure system as that in which the drug product is marketed.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →70 21 CFR 211.67(b)FDA cite ID 4303 Written procedures fail to include 8Read ▾
FDA’s wording
Written procedures for cleaning and maintenance fail to include [assignment of responsibility] [maintenance and cleaning schedules] [description in sufficient detail of methods, equipment and materials used] [description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance] [instructions for removal or obliteration of previous batch identification] [instructions for protection of clean equipment from contamination prior to use] [parameters relevant to the operation].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →70 21 CFR 211.68(b)FDA cite ID 4305 Backup data not assured as exact and complete 8Read ▾
FDA’s wording
Backup data is not assured as [exact] [complete] [secure from alteration, erasure or loss] through keeping hard copy or alternate systems.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →70 21 CFR 211.160(b)(4)FDA cite ID 4352 Calibration - at intervals, written program, remedial action 8Read ▾
FDA’s wording
The calibration of [instruments] [apparatus] [gauges] [recording devices] is not done at suitable intervals [in accordance with an established written program] [with provisions for remedial action in the event accuracy and/or precision limits are not met].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →70 21 CFR 212.30(b)FDA cite ID 21373 Equipment procedures 8Read ▾
FDA’s wording
You did not [implement procedures] [document your activities in accordance with your procedures] to ensure that all equipment is [cleaned] [suitable for its intended purposes] [properly installed, maintained, and capable of repeatedly producing valid results] that could reasonably be expected to adversely affect the identity, strength, quality, or purity of a PET drug, or give erroneous or invalid test results when improperly used or maintained.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →79 21 CFR 211.42(c)FDA cite ID 1194 Defined areas of adequate size for operations 7Read ▾
FDA’s wording
The [separate or defined areas] [control systems] necessary to prevent contamination or mix-ups are deficient.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →79 21 CFR 211.67(c)FDA cite ID 1227 Cleaning/maintenance records not kept 7Read ▾
FDA’s wording
Records are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →79 21 CFR 211.42(c)(5)FDA cite ID 1413 Mfg / Processing Operations Area 7Read ▾
FDA’s wording
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →79 21 CFR 211.42(c)(10)(vi)FDA cite ID 1436 Equipment to control conditions 7Read ▾
FDA’s wording
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →79 21 CFR 211.84(a)FDA cite ID 1801 Components withheld from use pending releaseBatch release decisions 7Read ▾
FDA’s wording
Each lot of [components] [drug product containers] [closures] is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.
CW · BATCH RELEASE DECISIONS
What an investigator may ask next
“Who authorized this batch release and what evidence was reviewed before the decision?”
Inspection scenario: Who Authorized This Batch Release? → Test a decision like this — free assessment →See the Batch Release Authorization Case File, a completed record of the evidence, judgment, risk, alternatives and QA release authority behind one batch-release decision. $149
79 21 CFR 211.198(b)(2)FDA cite ID 2619 Complaint Investigation/Follow-Up Findings 7Read ▾
FDA’s wording
Complaint records are deficient in that they do not include the findings of the [investigation] [follow-up].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →79 21 CFR 211.166(a)FDA cite ID 4357 Results not used for expiration dates, storage cond. 7Read ▾
FDA’s wording
Results of stability testing are not used in determining [appropriate storage conditions] [expiration dates].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →79 FDCA 501(a)(2)(A)FDA cite ID 22769 Media fills, failure 7Read ▾
FDA’s wording
Failure to conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging, and stressful conditions.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →87 21 CFR 211.22(a)FDA cite ID 1079 Contract drug products--lack of responsibility 6Read ▾
FDA’s wording
The quality control unit lacks responsibility for approving or rejecting drug products [manufactured] [processed] [packed] [held] under contract by another company.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →87 21 CFR 211.111FDA cite ID 1448 Establishment of time limitations 6Read ▾
FDA’s wording
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →87 21 CFR 211.80(b)FDA cite ID 1790 Handling and Storage to Prevent Contamination 6Read ▾
FDA’s wording
There was a failure to handle and store [components] [drug product containers] [closures] at all times in a manner to prevent contamination.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →87 21 CFR 211.180(c)FDA cite ID 1879 Records not made readily available to FDA 6Read ▾
FDA’s wording
Records associated with drug product [components] [containers] [closures] [labeling] [production] [control] [distribution] and within the retention period for such records, were not made readily available for authorized inspection.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →87 21 CFR 211.165(f)FDA cite ID 1891 Failing drug products not rejectedBatch release decisions 6Read ▾
FDA’s wording
Drug products failing to meet established [standards] [specifications] [quality control criteria] are not rejected.
CW · BATCH RELEASE DECISIONS
What an investigator may ask next
“Who authorized this batch release and what evidence was reviewed before the decision?”
Inspection scenario: Who Authorized This Batch Release? → Test a decision like this — free assessment →See the Batch Release Authorization Case File, a completed record of the evidence, judgment, risk, alternatives and QA release authority behind one batch-release decision. $149
87 21 CFR 314.80(c)(1)(i)FDA cite ID 6732 Late submission of 15-day report 6Read ▾
FDA’s wording
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →87 21 CFR 314.80(c)(2)FDA cite ID 6832 Late submission of annual safety reports 6Read ▾
FDA’s wording
Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →87 21 CFR 314.81(b)(2)FDA cite ID 8912 Timely submission 6Read ▾
FDA’s wording
An annual report was not submitted [each year] [within 60 days of the anniversary date of U.S. approval of the application] to the FDA division responsible for reviewing the application.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →87 FDCA 505-1(f)(4)FDA cite ID 21360 Failure to comply with REMS Implementation System 6Read ▾
FDA’s wording
An application holder did not [ensure wholesalers / distributors who distribute the drug are authorized to distribute the drug] [comply with the audit plan and schedule described in the REMS] [identify and address non-compliant authorized wholesalers / distributors] [maintain a Support / Call Center or a REMS Program website] [maintain the drug distribution and dispensing records to ensure restricted distribution], as required by your approved REMS Implementation System.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →87 FDCA 501(a)(2)(A)FDA cite ID 22766 Inadequate smoke studies 6Read ▾
FDA’s wording
Smoke studies [were not] [were inadequately] performed under dynamic conditions.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →87 FDCA 503B(a)(10)(A)FDA cite ID 22787 Drug product labels, fails to include 6Read ▾
FDA’s wording
The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →98 21 CFR 211.68(a)FDA cite ID 1261 Written calibration / inspection records not kept 5Read ▾
FDA’s wording
Records of the [calibration checks] [inspections] of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →98 21 CFR 211.122(d)FDA cite ID 1505 Label storage access limited to authorized personnel 5Read ▾
FDA’s wording
Access to the storage area for labels and labeling materials is not limited to authorized personnel.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →98 21 CFR 211.188(b)(2)FDA cite ID 2014 Identification of Equipment and Lines 5Read ▾
FDA’s wording
The batch production and control records are deficient in that they do not include the identity of major [equipment] [lines] used.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →98 21 CFR 211.194(c)FDA cite ID 2033 Testing and standardization of standards et. al. 5Read ▾
FDA’s wording
Laboratory records do not include complete records of any testing and standardization of laboratory [reference standards] [reagents] [standard solutions].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →98 21 CFR 211.194(a)(2)FDA cite ID 2399 Laboratory Test Method Verification 5Read ▾
FDA’s wording
Verification of the suitability of the testing methods is deficient in that they are not [performed under actual conditions of use] [documented on the laboratory records].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →98 21 CFR 211.100(a)FDA cite ID 3570 Approval and review of procedures 5Read ▾
FDA’s wording
Written procedures are not [drafted, reviewed and approved by the appropriate organizational units] [reviewed and approved by the quality control unit].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →98 21 CFR 211.165(d)FDA cite ID 3616 Acceptance criteria for sampling & testing 5Read ▾
FDA’s wording
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet [each appropriate specification] [appropriate statistical quality control criteria] as a condition for their approval and release.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →98 21 CFR 211.170(b)FDA cite ID 3629 Reserve samples identified, representative, stored 5Read ▾
FDA’s wording
Reserve drug product samples are not [appropriately identified] [representative of each lot or batch of drug product] [retained and stored under conditions consistent with product labeling].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →98 21 CFR 211.80(a)FDA cite ID 4306 Written Procedures Not Followed 5Read ▾
FDA’s wording
Written procedures are not followed for the [receipt] [identification] [storage] [handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers] [closures].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →98 21 CFR 211.142FDA cite ID 4340 Written warehousing procedures established/followed 5Read ▾
FDA’s wording
Procedures describing the warehousing of drug products are not [established] [followed].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →98 21 CFR 211.198(a)FDA cite ID 4389 Procedures to be written and followed 5Read ▾
FDA’s wording
Procedures describing the handling of all written and oral complaints regarding a drug product are not [established] [written] [followed].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →98 21 CFR 211.194(a)(2)FDA cite ID 4406 Suitability of testing methods verified 5Read ▾
FDA’s wording
The suitability of all testing methods is not verified under actual conditions of use.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →98 FDCA 501(a)(2)(A)FDA cite ID 22733 Beta-lactam, hazardous, highly potent drugs, prevention of cross-contamination 5Read ▾
FDA’s wording
[Beta-lactam drugs] [Hazardous drugs] [Highly potent drugs] were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →98 FDCA 501(a)(2)(A)FDA cite ID 22749 Production areas, difficult to clean/particle generating 5Read ▾
FDA’s wording
Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →112 21 CFR 211.28(a)FDA cite ID 1162 Protective Apparel Not Worn 4Read ▾
FDA’s wording
Protective apparel is not worn as necessary to protect drug products from contamination.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →112 21 CFR 211.130FDA cite ID 1626 Procedures are written, and followed 4Read ▾
FDA’s wording
Procedures designed to assure that correct [labels] [labeling] [packaging materials] are used for drug products are not [written] [followed].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →112 21 CFR 211.80(a)FDA cite ID 1787 Procedures To Be in Writing 4Read ▾
FDA’s wording
Written procedures are lacking which describe in sufficient detail the [receipt] [identification] [storage] [handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers] [closures].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →112 21 CFR 211.84(b)FDA cite ID 1803 Representative Samples Criteria 4Read ▾
FDA’s wording
The [number of containers to be sampled] [amount of material taken from each container] is not based upon appropriate criteria.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →112 21 CFR 211.84(e)FDA cite ID 1851 Rejecting When Specifications Not Met 4Read ▾
FDA’s wording
Failure to reject any lot of [components] [drug product containers] [closures] that did not meet the appropriate written specifications for identity, strength, quality, and purity.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →112 21 CFR 211.166(a)(2)FDA cite ID 1918 Stability sample storage conditions described 4Read ▾
FDA’s wording
The written stability program for drug products does not describe the storage conditions for samples retained for testing.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →112 21 CFR 211.166(c)(1)FDA cite ID 1928 Homeopathic drugs, assessment of stability 4Read ▾
FDA’s wording
There is no written assessment of stability of homeopathic drug products based at least on [testing or examination of the drug product for compatibility of the ingredients] [marketing experience with the drug product to indicate that there is no degradation of the product for the normal or expected period of use].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →112 21 CFR 211.180(e)(2)FDA cite ID 1957 Review of problem drugsInvestigation follow-up & annual review 4Read ▾
FDA’s wording
The procedures for the annual quality standards record evaluation are deficient in that they do not address a review of [complaint] [recall] [returned drug product] [salvaged drug product] [investigation] records for each drug product.
CW · INVESTIGATION FOLLOW-UP & ANNUAL REVIEW
What an investigator may ask next
“Who determined this CAPA was effective and what evidence supported that conclusion?”
Inspection scenario: Who Authorized This CAPA Closure? → CAPA effectiveness check → Test a decision like this — free assessment →See the CAPA Effectiveness Case File, a completed record of the evidence, judgment, residual risk, alternatives and authorization behind one CAPA closure. $149
112 21 CFR 211.188(a)FDA cite ID 2011 Accurate reproduction 4Read ▾
FDA’s wording
The batch production and control records are deficient in that they are not [an accurate reproduction of the appropriate master production or control record] [checked for accuracy, dated, and signed].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →112 21 CFR 211.186(b)(9)FDA cite ID 2205 Manufacturing Instructions and Specifications 4Read ▾
FDA’s wording
The master production and control records are deficient in that they do not include complete [manufacturing and control instructions] [sampling procedures] [testing procedures] [specifications] [special notations] [precautions to be followed].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →112 21 CFR 211.160(b)(4)FDA cite ID 3613 Establishment of calibration procedures 4Read ▾
FDA’s wording
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are [not written or followed] [deficiently written or followed].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →112 21 CFR 211.198(b)(2)FDA cite ID 4382 Written record of complaint to include findings, follow-up 4Read ▾
FDA’s wording
Written records of investigation of a drug complaint do not include [the findings of the investigation] [the follow-up].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →112 21 CFR 211.186(b)(9)FDA cite ID 4401 Complete instructions, procedures, specifications et. al. 4Read ▾
FDA’s wording
Master production and control records lack [complete manufacturing and control instructions] [sampling and testing procedures] [specifications] [special notations] [precautions to be followed].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →112 21 CFR 211.194(a)(1)FDA cite ID 4404 Sample identification and other information 4Read ▾
FDA’s wording
Laboratory records do not include [a description of the sample received for testing] [the source or location from where the sample was obtained] [the quantity of the sample] [the lot number or other distinctive code of the sample] [the date the sample was taken] [the date the sample was received for testing].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →112 21 CFR 211.42(b)FDA cite ID 4418 Adequate space lacking to prevent mix-ups and contamination 4Read ▾
FDA’s wording
The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between [different components] [drug product containers] [closures] [labeling] [in-process materials] [drug products] and to prevent contamination.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →112 21 CFR 212.60(d)FDA cite ID 17853 Supplies adequately controlled 4Read ▾
FDA’s wording
Your [identity] [purity] [quality] of [reagents] [solutions] [supplies] used in your testing procedures are not adequately controlled.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →112 FDCA 501(a)(2)(A)FDA cite ID 22742 Exposed to lower quality air/ISO 5 4Read ▾
FDA’s wording
[Sterile drugs] [Materials] were exposed to lower than ISO 5 quality air.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →112 FDCA 501(a)(2)(A)FDA cite ID 22763 Lack of/inadequate, environmental monitoring 4Read ▾
FDA’s wording
[Lack of] [Inadequate] routine environmental monitoring in the [ISO 5 area] [classified areas].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 211.25(b)FDA cite ID 1134 Supervisor Training/Education/Experience 3Read ▾
FDA’s wording
Individuals responsible for supervising the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 211.67(b)(2)FDA cite ID 1219 Cleaning SOPs/schedules 3Read ▾
FDA’s wording
Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 211.68(b)FDA cite ID 1256 Backup file not maintained 3Read ▾
FDA’s wording
Failure to maintain a backup file of data entered into the computer or related system.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 211.42(c)(10)(i)FDA cite ID 1430 Floors, walls, ceiling surfaces 3Read ▾
FDA’s wording
Aseptic processing areas are deficient in that [floors] [walls] [ceilings] are not smooth and/or hard surfaces that are easily cleanable.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 211.42(c)(10)(iii)FDA cite ID 1433 Air Supply 3Read ▾
FDA’s wording
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 211.122(a)FDA cite ID 1495 Written procedures describing in detail 3Read ▾
FDA’s wording
There is a lack of written procedures describing in sufficient detail the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of labeling and packaging materials.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 211.122(a)FDA cite ID 1496 Sampling/testing of labeling/packaging materials 3Read ▾
FDA’s wording
Labeling and packaging materials are not [representatively sampled] [examined] [tested] upon receipt and before use in packaging and labeling of a drug product.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 211.166(a)(1)FDA cite ID 1917 Sample size - test intervals 3Read ▾
FDA’s wording
The written stability program for drug products does not include [sample size] [test intervals] based on statistical criteria for each attribute examined to assure valid estimates of stability.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 211.167(c)FDA cite ID 1938 Controlled release dosage form testing 3Read ▾
FDA’s wording
Each batch of controlled-release dosage form drug product is not laboratory tested to determine conformance to the specifications for the rate of release for each active ingredient.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 211.182FDA cite ID 1976 Specific information required in individual logs 3Read ▾
FDA’s wording
Individual equipment logs do not show [time] [date] [product] [lot number of each batch processed].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 211.186(a)FDA cite ID 2008 Written procedures followed 3Read ▾
FDA’s wording
Procedures for the preparation of master production and control records are not [described in a written procedure] [followed].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 211.65(a)FDA cite ID 3445 Equipment construction - reactive surfaces 3Read ▾
FDA’s wording
Equipment surfaces that contact [components] [in-process materials] [drug products] are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 211.110(c)FDA cite ID 3592 In-process materials characteristics testing 3Read ▾
FDA’s wording
In-process materials are not tested for [identity] [strength] [quality] [purity] and approved or rejected by the quality control unit [during the production process] [after storage for long periods].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 211.160(b)(3)FDA cite ID 3611 Acceptance of drug products 3Read ▾
FDA’s wording
Determinations of conformance to appropriate written specifications for acceptance are [not made] [deficient] for drug products.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 211.165(c)FDA cite ID 4355 Sampling and testing plans not followed 3Read ▾
FDA’s wording
Written procedures for sampling and testing plans are not followed for each drug product.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 211.176FDA cite ID 4364 Failing to test for penicillin cross-contamination 3Read ▾
FDA’s wording
Non-penicillin drug products were not tested for the presence of penicillin, when a reasonable possibility existed that a non-penicillin drug product has been exposed to a cross-contamination with penicillin.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 211.188(b)(8)FDA cite ID 4372 Labeling control records including specimens or copies 3Read ▾
FDA’s wording
Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 211.188(b)(1)FDA cite ID 4379 Dates not included for each significant step 3Read ▾
FDA’s wording
Batch production and control records do not include dates of each significant step in the [manufacture] [processing] [packing] [holding] of the batch for each batch of drug product produced.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 211.194(a)(5)FDA cite ID 4410 Calculations performed are in the records 3Read ▾
FDA’s wording
Laboratory records do not include a record of all calculations performed in connection with the test.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 314.80(c)(2)FDA cite ID 6831 Late submission of quarterly safety reports 3Read ▾
FDA’s wording
Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 314.80(d)FDA cite ID 6835 Failure to submit scientific article 3Read ▾
FDA’s wording
A postmarketing 15-day Alert report based upon scientific literature was not accompanied by a copy of the published article.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 212.20(c)FDA cite ID 17760 Specifications and processes 3Read ▾
FDA’s wording
You did not approve or reject, before implementation, [any initial] [any proposed changes to existing] [specifications] [methods] [processes or procedures] to ensure that they maintain the identity, strength, quality, and purity of a PET drug.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 212.20(d)FDA cite ID 17763 Determination need for investigationDeviations & investigations 3Read ▾
FDA’s wording
When errors occurred or a production batch or any component of the batch, failed to meet specifications, you did not [determine the need for an investigation] [conduct an investigation] [take appropriate corrective actions] when necessary.
CW · DEVIATIONS & INVESTIGATIONS
What an investigator may ask next
“Who determined the root cause and what evidence supported the determination?”
Inspection scenario: Who Authorized the Root Cause Determination? → Test a decision like this — free assessment →See the Deviation Closure Case File, a completed record of the investigation evidence, root-cause judgment, risk, alternatives and Quality closure authority behind one deviation closure. $149
130 21 CFR 212.60(c)FDA cite ID 17851 Analytical methods 3Read ▾
FDA’s wording
Your laboratory analytical methods are not [suitable for their intended use] [sufficiently sensitive] [sufficiently specific] [sufficiently accurate] [sufficiently reproducible].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 212.70(c)FDA cite ID 17877 Conform to specs prior to release 3Read ▾
FDA’s wording
You did not conduct an appropriate laboratory determination to ensure that each batch of a PET drug product conforms to specifications before final release.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 212.71(c)FDA cite ID 17898 Correction of problems 3Read ▾
FDA’s wording
You did not take [appropriate] action to correct any identified problems to prevent recurrence of a nonconforming product or other quality problem.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 212.110(b)FDA cite ID 17927 Record quality 3Read ▾
FDA’s wording
All records including those not stored at your inspected establishment are not [legible] [stored to prevent deterioration or loss] [readily available for review and copying by FDA employees].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 21 CFR 314.80(c)(2)(ii)(B)FDA cite ID 18025 Late submission of an ICSR 3Read ▾
FDA’s wording
You failed to submit an ICSR for the reporting period [within 30 days of the close of the quarter] [within 60 days of the anniversary date of the approval of the application].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 FDCA 505-1(f)(3)(A)FDA cite ID 21354 Failure to comply with REMS Elements to Assure Safe Use (ETASU) A 3Read ▾
FDA’s wording
An application holder did not [ensure healthcare providers (HCPs) who prescribe the drug are specially certified] [ensure mechanisms are in place that allow healthcare providers (HCPs) the ability to complete the certification process] [secure a database of certified healthcare providers (HCPs)] [identify and address non-compliant certified healthcare providers (HCPs)] [make training available to prescribing healthcare providers (HCPs)], as required by your approved REMS Element to Assure Safe Use (ETASU) A.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →130 FDCA 501(a)(2)(A)FDA cite ID 22761 Lack of disinfection, equipment/supplies from lower to higher quality air 3Read ▾
FDA’s wording
Lack of disinfection of [equipment] [supplies] at each transition from areas of lower quality air to areas of higher quality air.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.28(a)FDA cite ID 1159 Clothing appropriate for duties performed 2Read ▾
FDA’s wording
Clothing of personnel engaged in the [manufacturing] [processing] [packing] [holding] of drug products is not appropriate for the duties they perform.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.105(b)FDA cite ID 1411 Distinctive ID or code not recorded in batch record 2Read ▾
FDA’s wording
The batch records do not record the distinctive [identification number] [code] [name of equipment] to identify major equipment to show the specific equipment used in the manufacture of a batch of a drug product.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.42(c)(9)FDA cite ID 1420 Control / Lab Operations Area 2Read ▾
FDA’s wording
Separate or defined areas to prevent contamination or mix-ups are deficient regarding laboratory controls and operations.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.42(c)(10)FDA cite ID 1421 Aseptic Processing Area 2Read ▾
FDA’s wording
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.122(d)FDA cite ID 1504 Labels and labeling stored separately 2Read ▾
FDA’s wording
Labels and other labeling materials are not stored separately with suitable identification for each different drug product, strength, dosage form or quantity of contents.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.125(f)FDA cite ID 1550 Procedures Written and Followed 2Read ▾
FDA’s wording
Procedures describing in sufficient detail the controls employed for the issuance of labeling are not [written] [followed].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.130(a)FDA cite ID 1629 Prevention of cross contamination, mix-ups 2Read ▾
FDA’s wording
There is insufficient physical or spatial separation from operations and other drug products to prevent mix-ups and cross-contamination.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.84(c)(4)FDA cite ID 1823 Top/Middle/Bottom container sampling 2Read ▾
FDA’s wording
Sampling procedures are deficient regarding sampling components from the top, middle, and bottom of container.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.84(d)(6)FDA cite ID 1849 Objectionable microbiological contamination 2Read ▾
FDA’s wording
Each lot of a [component] [drug product containers] [closures] liable to objectionable microbiological contamination is deficiently subjected to microbiological tests before use.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.180(b)FDA cite ID 1876 Record maintenance 1 year (except exempt OTC) 2Read ▾
FDA’s wording
All records of [production] [control] [distribution] [components] [drug product containers] [closures] [labeling] associated with a batch of drug product were not maintained at least one (1) year after the expiration date.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.166(b)FDA cite ID 1927 Accelerated stability studies 2Read ▾
FDA’s wording
Accelerated stability studies, combined with basic stability information, used to support tentative expiration dates are not supported with ongoing full shelf life studies.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.167(a)FDA cite ID 1932 Sterility/pyrogen-free testing 2Read ▾
FDA’s wording
Each batch of drug product purporting to be [sterile] [pyrogen-free] is not laboratory tested to determine conformance to such requirements.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.186(a)FDA cite ID 2007 Signature and checking of records -- 2 persons 2Read ▾
FDA’s wording
The master production and control records for each batch size of drug product are not [prepared, dated, and signed by one person with a full handwritten signature] [independently checked, dated, and signed by a second person].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.188(b)(7)FDA cite ID 2019 Documentation of Actual Yield and Theoretical Yield 2Read ▾
FDA’s wording
The batch production and control records are deficient in that they do not include a statement of the [actual yield] [percentage of theoretical yield].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.188(b)(8)FDA cite ID 2020 Labeling Control Records and Label Copies 2Read ▾
FDA’s wording
The batch production and control records are deficient in that they do not include [complete labeling control records] [specimen] [copy] of labeling.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.188(b)(11)FDA cite ID 2023 Identification of Persons Performing Significant Steps 2Read ▾
FDA’s wording
The batch production and control records are deficient in that they do not include identification of persons [performing] [supervising] [checking] each significant step in the operation.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.194(d)FDA cite ID 2034 Laboratory equipment calibration records 2Read ▾
FDA’s wording
Laboratory records do not include complete records of the periodic calibration of laboratory [instruments] [apparatus] [gauges] [recording devices].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.196FDA cite ID 2044 Distribution Record Requirements 2Read ▾
FDA’s wording
Distribution records do not contain the [name and strength of the drug product] [description of dosage form] [name and address of consignee] [date and quantity shipped] [lot or control number of drug product].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.194(a)(6)FDA cite ID 2404 Comparison of Test Results to Specifications 2Read ▾
FDA’s wording
Laboratory records are deficient in that they do not include a statement of the results of tests and how they compare to the established [specifications] [standards].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.198(b)FDA cite ID 2569 Maintenance of Complaint File 2Read ▾
FDA’s wording
Complaint procedures are deficient in that written complaint records are not maintained in a file designated for drug product complaints.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.48(a)FDA cite ID 3553 Plumbing System Defects 2Read ▾
FDA’s wording
The plumbing system contains defects that could contribute to the contamination of drug products.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.56(b)FDA cite ID 3561 Written sanitation procedures lacking 2Read ▾
FDA’s wording
There is a lack of written procedures [assigning responsibility] [providing cleaning schedules] [describing in sufficient detail the methods, equipment and materials to be used] for sanitation.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.89FDA cite ID 3569 Quarantine of Rejected Components et. al. 2Read ▾
FDA’s wording
Rejected [components] [drug product containers] [closures] are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.100(a)FDA cite ID 3571 Changes to Procedures Not Reviewed, ApprovedChange control 2Read ▾
FDA’s wording
Changes to written procedures are not [drafted, reviewed and approved by the appropriate organizational unit] [reviewed and approved by the quality control unit].
CW · CHANGE CONTROL
What an investigator may ask next
“Who made the regulatory impact determination for this change?”
Inspection scenario: Who Approved This Change Control? → Test a decision like this — free assessment →160 21 CFR 211.105(a)FDA cite ID 3582 Identification of containers, lines, equipment 2Read ▾
FDA’s wording
All [compounding and storage containers] [processing lines] [major equipment] used during the production of a batch of drug product is not properly identified at all times to indicate [contents] [the phase of processing of the batch].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.110(d)FDA cite ID 3594 Rejected in-process materials not quarantined 2Read ▾
FDA’s wording
Rejected in-process materials are not [identified] [controlled under a quarantine system] to prevent their use in manufacturing or processing operations for which they are unsuitable.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.160(a)FDA cite ID 3602 Deviations from laboratory control requirements 2Read ▾
FDA’s wording
Deviations from written [specifications] [standards] [sampling plans] [test procedures] [laboratory mechanisms] are not [recorded] [justified].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.160(b)(2)FDA cite ID 3607 Acceptance of in-process materials 2Read ▾
FDA’s wording
Determinations of conformance to appropriate written specifications for acceptance are [not made] [deficient] for in-process materials.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.56(b)FDA cite ID 4302 Written sanitation procedures not followed 2Read ▾
FDA’s wording
Written procedures for sanitation are not followed.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.68(b)FDA cite ID 4304 Written record not kept of program and validation dataValidation 2Read ▾
FDA’s wording
A written record of the program along with appropriate validation data has not been maintained in situations where backup data is eliminated by computerization or other automated processes.
CW · VALIDATION
What an investigator may ask next
“Who authorized the validation conclusion?”
Inspection scenario: Who Authorized the Process Validation Conclusion? → Test a decision like this — free assessment →160 21 CFR 211.80(d)FDA cite ID 4307 Status of Each Lot Identified 2Read ▾
FDA’s wording
Each lot of [components] [drug product containers] [closures] was not appropriately identified as to its status in terms of being quarantined, approved or rejected.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.84(d)(6)FDA cite ID 4320 Microbiological Contamination Exam 2Read ▾
FDA’s wording
Each lot of a [component] [drug product container] [closure] that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.160(b)(2)FDA cite ID 4349 In-process samples representative, identified properly 2Read ▾
FDA’s wording
Samples taken of in-process materials for determination of conformance to specifications are not [representative] [properly identified].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.165(d)FDA cite ID 4354 Acceptance/Rejection Levels 2Read ▾
FDA’s wording
The statistical quality control criteria fail to include appropriate [acceptance levels] [rejection levels].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 211.188(b)(12)FDA cite ID 4368 Investigations made into any unexplained discrepancyDeviations & investigations 2Read ▾
FDA’s wording
Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not the batch of drug product had already been distributed.
CW · DEVIATIONS & INVESTIGATIONS
What an investigator may ask next
“Who determined the root cause and what evidence supported the determination?”
Inspection scenario: Who Authorized the Root Cause Determination? → Test a decision like this — free assessment →See the Deviation Closure Case File, a completed record of the investigation evidence, root-cause judgment, risk, alternatives and Quality closure authority behind one deviation closure. $149
160 21 CFR 211.194(a)(4)FDA cite ID 4409 Data secured in course of each test 2Read ▾
FDA’s wording
Laboratory records do not include a complete record of all data secured in the course of each test, including all [graphs] [charts] [spectra] from laboratory instrumentation, properly identified to show the [specific component] [drug product container] [closure] [in-process material] [lot tested] [drug product tested].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 314.81(b)(1)(ii)FDA cite ID 8907 Contamination, chemical or physical change, deterioration 2Read ▾
FDA’s wording
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning [bacteriological contamination] [significant chemical, physical, or other change or deterioration] in a distributed drug product.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 212.10FDA cite ID 17722 Lack Adequate Resources, Facilities, Equipment. 2Read ▾
FDA’s wording
You lack adequate [resources] [facilities] [equipment] to enable your personnel to perform their functions.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 212.10FDA cite ID 17723 Personnel not qualified 2Read ▾
FDA’s wording
You lack [a sufficient number of] personnel with the necessary [education] [background] [training] [experience] to perform their assigned functions.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 212.50(a)FDA cite ID 17813 Written control procedures 2Read ▾
FDA’s wording
You did not have written production and process control procedures to [ensure] [document] that [all key process parameters are controlled] [any deviations from the procedures are justified].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 212.60(e)FDA cite ID 17855 Equipment 2Read ▾
FDA’s wording
All equipment used to perform the testing is not [suitable for its intended purposes] [capable of producing valid results].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 212.60(g)FDA cite ID 17859 Test records complete (general) 2Read ▾
FDA’s wording
Each laboratory used to perform tests related to the production of a PET drug did not keep complete records of all tests performed to ensure compliance with established specifications and standards, including examinations and assays.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 21 CFR 212.71(b)FDA cite ID 17941 Documentation of Non-Conforming Product Investigation 2Read ▾
FDA’s wording
You did not document [the results of the investigation] [what happened to the rejected PET drug product] for a PET drug product that did not meet specifications.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 FDCA 505-1(f)(3)(B)FDA cite ID 21355 Failure to comply with REMS Elements to Assure Safe Use (ETASU) B 2Read ▾
FDA’s wording
An application holder did not [ensure pharmacies that dispense the drug are specially certified] [ensure mechanisms are in place that allow pharmacies the ability to complete the certification process] [maintain a validated, secure database of certified pharmacies] [identify and address non-compliant certified pharmacies], as required by your approved REMS Element to Assure Safe Use (ETASU) B.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 FDCA 501(a)(2)(A)FDA cite ID 22732 Contamination, production area/adjacent areas 2Read ▾
FDA’s wording
Contamination was observed in your [production area] [areas adjacent to production areas].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 FDCA 501(a)(2)(A)FDA cite ID 22758 Non-sterile disinfecting agents, ISO 5 area/classified areas 2Read ▾
FDA’s wording
Use of non-sterile [disinfecting agents] [cleaning pads] [cleaning wipes] in the [ISO 5 area] [classified areas].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 FDCA 501(a)(2)(A)FDA cite ID 22759 Sporicidal agent, ISO 5/classified areas 2Read ▾
FDA’s wording
Use of a sporicidal agent in the facility's [ISO 5 areas] [classified areas] was [lacking] [improper] [infrequent].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 FDCA 501(a)(2)(A)FDA cite ID 22760 Failure to clean and disinfect/sterilize equipment, ISO 5 area 2Read ▾
FDA’s wording
Failure to appropriately and regularly clean and disinfect or sterilize equipment located in the ISO 5 area.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 FDCA 503B(b)(2)(A)FDA cite ID 22779 All inclusive product report, not submitted 2Read ▾
FDA’s wording
Your outsourcing facility has not submitted a report to FDA identifying a product compounded during the previous six months as required by section 503B(b)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →160 FDCA 503B(a)(10)(B)FDA cite ID 22789 Drug product container, fails to include 2Read ▾
FDA’s wording
The container of your outsourcing facility's drug products does not include information required by section 503B(a)(10)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.67(b)(1)FDA cite ID 1218 Cleaning SOP/responsibility 1Read ▾
FDA’s wording
Procedures for the cleaning and maintenance of equipment are deficient regarding assignment of responsibility for cleaning and maintaining equipment.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.67(b)(5)FDA cite ID 1223 Cleaning SOPs/equipment protection 1Read ▾
FDA’s wording
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment from contamination prior to use.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.67(b)(6)FDA cite ID 1224 Cleaning SOP/inspection 1Read ▾
FDA’s wording
Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.42(c)(1)FDA cite ID 1251 Incoming material area 1Read ▾
FDA’s wording
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the receipt, identification, storage, and withholding from use of [components] [drug product containers] [closures] [labeling] pending sampling, testing, or examination by the quality control unit before release for manufacturing or packaging.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.42(d)FDA cite ID 1266 Penicillin processing area not kept separate 1Read ▾
FDA’s wording
The operations relating to the [manufacture] [processing] [packing] of penicillin are not performed in facilities separate from those used for other drug products for human use.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.101(d)FDA cite ID 1388 Component addition checked by 2nd person 1Read ▾
FDA’s wording
Each component is not added to a batch by one person and verified by a second person.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.42(c)(2)FDA cite ID 1396 Rejected Material Area 1Read ▾
FDA’s wording
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the holding of rejected [components] [drug product containers] [closures] [labeling] before disposition.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.42(c)(4)FDA cite ID 1409 In-Process Material Area 1Read ▾
FDA’s wording
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the storage of in-process materials.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.42(c)(7)FDA cite ID 1418 Quarantined Drug Products Area 1Read ▾
FDA’s wording
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the quarantine storage of drug products prior to release.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.115(a)FDA cite ID 1454 Reprocessing procedures not written or followed 1Read ▾
FDA’s wording
Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics are not [written] [followed].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.122(b)FDA cite ID 1498 Labeling and packaging improperly approved/released 1Read ▾
FDA’s wording
Labeling and packaging materials not meeting the appropriate written specifications were [approved] [released for use].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.130(c)FDA cite ID 1632 Lot or control number assigned 1Read ▾
FDA’s wording
The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.130(d)FDA cite ID 1633 Examination of packaging and labeling 1Read ▾
FDA’s wording
Examination of packaging and labeling materials for suitability and correctness before packaging operations is [not performed] [not documented in the batch production records].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.130(e)FDA cite ID 1637 Packaging line inspection after use 1Read ▾
FDA’s wording
Inspection of the [packaging] [labeling] facilities is not done after use to assure that materials not suitable for subsequent operations have been removed.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.134(a)FDA cite ID 1722 Correct labels during finishing operations 1Read ▾
FDA’s wording
Packaged and labeled products are not examined during finishing operations to provide assurance that containers and packages in the lot have the correct label.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.137(b)FDA cite ID 1768 Storage conditions 1Read ▾
FDA’s wording
Drug product expiration dates are not related to the storage conditions stated on the labeling, as determined by stability studies.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.80(d)FDA cite ID 1794 Disposition recorded by lot identification 1Read ▾
FDA’s wording
The distinctive code for each lot of [components] [drug product containers] [closures] is not used in recording the disposition of each lot.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.80(d)FDA cite ID 1796 Identification of Each Lot in Each Shipment 1Read ▾
FDA’s wording
Each lot in each shipment received was not identified with a distinctive code for each container or grouping of containers for [components] [drug product containers] [closures].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.94(b)FDA cite ID 1868 Protection from external factors 1Read ▾
FDA’s wording
Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.94(c)FDA cite ID 1869 Containers & Closures Clean, Sterilized, Pyrogen-free 1Read ▾
FDA’s wording
Drug product [containers] [closures] were not [clean] [sterilized and processed to remove pyrogenic properties] to assure that they are suitable for their intended use.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.165(c)FDA cite ID 1886 Sampling and testing plans not described 1Read ▾
FDA’s wording
Sampling and testing plans for drug products are not described in written procedures which include the [method of sampling] [number of units per batch to be tested].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.180(e)(1)FDA cite ID 1956 Representative Number of Batches for Annual ReviewInvestigation follow-up & annual review 1Read ▾
FDA’s wording
The procedures for the annual quality standards record evaluation are deficient in that they do not address a review of a representative number of [approved] [rejected] batches.
CW · INVESTIGATION FOLLOW-UP & ANNUAL REVIEW
What an investigator may ask next
“Who determined this CAPA was effective and what evidence supported that conclusion?”
Inspection scenario: Who Authorized This CAPA Closure? → CAPA effectiveness check → Test a decision like this — free assessment →See the CAPA Effectiveness Case File, a completed record of the evidence, judgment, residual risk, alternatives and authorization behind one CAPA closure. $149
210 21 CFR 211.180(f)FDA cite ID 1958 Responsible firm officials notified in writing 1Read ▾
FDA’s wording
Procedures are not established which are designed to assure that the responsible officials of the firm, if they are not personally involved in or immediately aware of such actions, are notified in writing of [investigations conducted] [recalls] [reports of inspectional observations issued by FDA] [any regulatory actions brought by FDA relating to good manufacturing practices].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.182FDA cite ID 1978 Personnel dating/signing equipment log 1Read ▾
FDA’s wording
The persons [performing] [double-checking] the cleaning and maintenance are not [dating] [signing or initialing] the equipment cleaning and use log.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.184(c)FDA cite ID 2003 Individual inventory record 1Read ▾
FDA’s wording
Records fail to include an individual inventory record of each [component] [reconciliation of the use of each component] [drug product container] [drug product closure] with sufficient information to allow determination of any associated batch or lot of drug product.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.188(b)(1)FDA cite ID 2013 Significant Step Accomplishment Dates 1Read ▾
FDA’s wording
The batch production and control records are deficient in that they do not include dates of accomplished significant steps.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.188(b)(10)FDA cite ID 2022 Documentation of Sampling Performed 1Read ▾
FDA’s wording
The batch production and control records are deficient in that they do not include documentation of sampling performed.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.188(b)(13)FDA cite ID 2025 Results of drug product inspections and examinations 1Read ▾
FDA’s wording
The batch production and control records are deficient in that they do not include results of drug product [examinations] [inspections].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.194(e)FDA cite ID 2035 Stability testing records not included 1Read ▾
FDA’s wording
Laboratory records do not include complete records of all stability testing performed.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.186(b)(2)FDA cite ID 2197 Active Ingredient Name and Weight 1Read ▾
FDA’s wording
The master production and control records are deficient in that they do not include the [name] [weight] of each active ingredient per dosage unit or unit of weight statement of total weight or measure of any dosage unit.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.194(a)(8)FDA cite ID 2406 Identification of Person Performing Review of Lab Records 1Read ▾
FDA’s wording
Laboratory records are deficient in that they do not include the [initials] [signature] of the second person reviewing the record for accuracy.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.198(b)(1)FDA cite ID 2618 Complaint Record required information 1Read ▾
FDA’s wording
Complaint records are deficient in that they do not include the known [name and strength of the drug product] [lot number] [name of complainant] [nature of complaint] [reply to complainant].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.46(c)FDA cite ID 3550 Exhaust systems inadequate to control air contamination 1Read ▾
FDA’s wording
Adequate exhaust systems or other systems to control contaminants are lacking in areas where air contamination occurs during production.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.48(b)FDA cite ID 3555 Drains--Size, Back-siphonage Prevention 1Read ▾
FDA’s wording
Drains are not [of adequate size] [provided with an air break or other mechanical device to prevent back-siphonage where connected directly with a sewer].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.56(c)FDA cite ID 3562 Written procedures lacking for use of pesticides etc. 1Read ▾
FDA’s wording
Written procedures are lacking for the use of [rodenticides] [insecticides] [fungicides] [fumigating agents] [cleaning and sanitizing agents] designed to prevent the contamination of [equipment] [components] [drug product containers] [closures] [packaging, labeling materials] [drug products].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.101(d)FDA cite ID 3581 Verification of component addition 1Read ▾
FDA’s wording
Each component is not added to the batch by one person and verified by a second person..
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.160(b)(1)FDA cite ID 3606 Retesting 1Read ▾
FDA’s wording
The specifications for [components] [drug product containers] [closure] are deficient in that they do not include appropriate retesting requirements.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.160(b)(2)FDA cite ID 3609 In-process sample representation/identification 1Read ▾
FDA’s wording
In-process samples are not [representative] [properly identified].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.160(b)(3)FDA cite ID 3612 Sampling/testing of drug products 1Read ▾
FDA’s wording
The specifications for drug products are deficient in that they do not include a description of the [sampling plan] [testing procedures] for drug products.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.160(b)(4)FDA cite ID 3614 Written calibration procedures 1Read ▾
FDA’s wording
Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific [directions] [schedules] [limits for accuracy and precision] [provisions for remedial action if limits are not met].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.160(b)(4)FDA cite ID 3615 Test devices not meeting specifications 1Read ▾
FDA’s wording
Test devices are deficient in that [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications are used.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.170(a)FDA cite ID 3623 Active ingredient retained sample kept 1Read ▾
FDA’s wording
A sample which is representative of each lot in each shipment of each active ingredient is not [appropriately identified] [retained].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.170(a)FDA cite ID 3624 Reserve sample quantity - active ingredients only 1Read ▾
FDA’s wording
The reserve sample of active ingredient does not consist of at least twice the quantity necessary for all tests required to determine whether the active ingredient meets its established specifications.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.170(b)FDA cite ID 3630 Drug product reserve containers 1Read ▾
FDA’s wording
Drug product reserve samples are not stored in [the same immediate container-closure system as the marketed product] [an immediate container-closure system that has essentially the same characteristics as the marketed product].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.84(d)(3)FDA cite ID 4316 Testing Containers & Closures Conformity with Specs 1Read ▾
FDA’s wording
Containers and closures are not tested for conformance with all appropriate written procedures.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.110(b)FDA cite ID 4324 In-process materials specifications testing 1Read ▾
FDA’s wording
Examination and testing of samples is not done to assure that in-process materials conform to specifications.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.110(a)FDA cite ID 4325 Control procedures fail to include the following 1Read ▾
FDA’s wording
Control procedures fail to include [tablet or capsule weight variation] [disintegration time] [adequacy of mixing to assure uniformity and homogeneity] [dissolution time and rate] [clarity, completeness or pH of solutions].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.122(a)FDA cite ID 4328 Written procedures not followed 1Read ▾
FDA’s wording
Written procedures for the [receipt] [identification] [storage] [handling] [sampling] [examination] [testing] of packaging and labeling materials are not followed.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.150(b)FDA cite ID 4338 Recall facilitation 1Read ▾
FDA’s wording
A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary, has not been established.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.160(b)(1)FDA cite ID 4345 Samples (various types) representative, identified properly 1Read ▾
FDA’s wording
Samples taken to determine conformance to appropriate written specifications for the acceptance of each lot within each shipment of [components] [drug product containers] [closures] [labeling] are not [representative] [adequately identified].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.160(b)(3)FDA cite ID 4350 Drug products-sampling procedures/specifications 1Read ▾
FDA’s wording
Laboratory controls do not include a determination of conformance to [written descriptions of sampling procedures] [appropriate specifications] for drug products.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.160(b)(3)FDA cite ID 4351 Drug products - samples representative, identified properly 1Read ▾
FDA’s wording
Samples taken of drug products for determination of conformance to written specifications are not [representative] [properly identified].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.160(b)(4)FDA cite ID 4353 Instruments, apparatus, et. al. not meeting specs 1Read ▾
FDA’s wording
The use of [instruments] [apparatus] [gauges] [recording devices] not meeting established specifications was observed.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.170(b)(1)FDA cite ID 4359 Retention time of reserve samples, in general 1Read ▾
FDA’s wording
You did not retain reserve samples for drug products for one year after the expiration dates of the drug products.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.170(b)FDA cite ID 4360 Reserve drug product sample quantity - all tests 1Read ▾
FDA’s wording
The reserve sample of drug product does not consist of at least twice the quantity necessary to perform all the required tests of drug product.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.188(b)(11)FDA cite ID 4369 Identification of persons involved, each significant step 1Read ▾
FDA’s wording
Batch production and control records do not include the identification of the persons [performing] [directly supervising] [checking] each significant step in the operation, for each batch of drug product produced.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.188(b)(5)FDA cite ID 4375 In-process and laboratory control results 1Read ▾
FDA’s wording
Batch production and control records do not include [in-process] [laboratory control] results for each batch of drug product produced.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.188(b)(2)FDA cite ID 4378 Identity of major equipment and lines used 1Read ▾
FDA’s wording
Batch production and control records do not include the identity of individual major [equipment] [lines] used for each batch of drug product produced.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.198(a)FDA cite ID 4388 Complaints reviewed by Quality Control Unit 1Read ▾
FDA’s wording
Written procedures describing the handling of complaints do not include provisions for [review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications] [a determination as to the need for an investigation of any unexplained discrepancy] [explaining the reasons for the failure of the batch or any of its components to meet specifications].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.186(b)(8)FDA cite ID 4400 Description of containers, labels, et. al. 1Read ▾
FDA’s wording
Master production and control records lack [a description of the drug product containers, closures and packaging materials] [a specimen or copy of each label and all other labeling] [the signatures and dates entered by the person or persons responsible for the approval of labeling].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.194(a)(2)FDA cite ID 4407 Reference and method not stated 1Read ▾
FDA’s wording
Laboratory records of methods of testing used do not [indicate the method] [provide the reference] when employing methods in [recognized standard references] [an approved new drug application and the referenced method is not modified].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.194(a)(6)FDA cite ID 4411 Test results, comparison with standards not included 1Read ▾
FDA’s wording
Laboratory records do not include a statement of the results of tests and how the results compare with established standards of identity, strength, quality, and purity for the [component] [drug product container] [closure] [in-process material] [drug product] tested.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.204FDA cite ID 4414 Record information maintained 1Read ▾
FDA’s wording
Records of returned drug products are not maintained.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 310.305(c)FDA cite ID 6705 Failure to submit ADE report 1Read ▾
FDA’s wording
Adverse drug experience information has not been reported to FDA.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 314.80(b)FDA cite ID 6728 Failure to review ADE information 1Read ▾
FDA’s wording
Adverse drug experience information obtained or otherwise received from any source was not [promptly] reviewed, including information from [commercial marketing experience] [post marketing clinical investigations] [post marketing epidemiological/surveillance activities] [reports in the scientific literature] [unpublished scientific papers].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 314.80(c)(1)(ii)FDA cite ID 6735 Failure to investigate serious, unexpected events 1Read ▾
FDA’s wording
Adverse drug experiences that were the subject of post marketing 15-day reports were not [promptly] investigated.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 212.30(c)FDA cite ID 17753 Contact surfaces 1Read ▾
FDA’s wording
Your equipment is not [constructed] [maintained] so that surfaces that contact [components] [in-process materials] [PET drugs] are not reactive, additive, or absorptive so as to alter the quality of the PET drugs.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 212.20(a)FDA cite ID 17755 Oversight of production operations 1Read ▾
FDA’s wording
You did not oversee production operations in a manner to ensure that each PET drug [meets the requirements of the FD&C Act as to safety] [has the identity and strength that it is supposed to have] [meets the quality and purity characteristics that it is supposed to have].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 212.40(b)FDA cite ID 17772 Written specifications - components 1Read ▾
FDA’s wording
You did not establish appropriate written specifications for the [identity] [quality] [purity] of components.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 212.40(b)FDA cite ID 17773 Written specifications - containers and closures 1Read ▾
FDA’s wording
You did not establish appropriate written specifications for the [identity] [quality] of drug product [containers] [closures].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 212.40(c)FDA cite ID 17778 Use of reliable suppliers 1Read ▾
FDA’s wording
You did not use a reliable supplier as a source of each lot of [component] [container] [closure].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 212.50(b)FDA cite ID 17814 Master Production and Control Records 1Read ▾
FDA’s wording
You did not have master production and control records that document all steps in the PET drug production process.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 212.50(c)FDA cite ID 17816 Unique record for each batch 1Read ▾
FDA’s wording
Each time a batch of a PET drug is produced, your firm does not create a unique batch production and control record.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 212.50(b)(6)FDA cite ID 17821 Action limits on radiochemical yield 1Read ▾
FDA’s wording
Your master production and control records did not include a statement of action limits on radiochemical yield.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 212.50(c)(8)FDA cite ID 17836 Testing results 1Read ▾
FDA’s wording
Your batch production record did not include testing results.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 212.50(d)FDA cite ID 17841 Production area & equipment checks 1Read ▾
FDA’s wording
Your [production area] [equipment in the production area] was not checked to ensure [cleanliness] [suitability] immediately before use.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 212.60(b)FDA cite ID 17850 Lab sampling and test procedures 1Read ▾
FDA’s wording
Each laboratory did not have [sampling] [testing] procedures which are designed to ensure that [components] [in-process materials] [PET drug products] conform to appropriate standards including established standards of identity, strength, quality and purity.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 212.60(f)FDA cite ID 17857 Lab written procedures 1Read ▾
FDA’s wording
Laboratory written procedures are not [established] [followed] to ensure that the lab equipment is routinely [calibrated] [inspected] [checked] [maintained].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 212.61(a)FDA cite ID 17867 Stability testing program 1Read ▾
FDA’s wording
You did not [establish] [follow] [maintain] a written testing program to assess the stability characteristics of your PET drug products.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 212.70(d)(2)FDA cite ID 17882 Data and documentation review 1Read ▾
FDA’s wording
You did not [establish] [follow] procedures to ensure that each batch or sub-batch of a PET drug product was not given final release until associated laboratory data and documentation were reviewed and PET drug products were demonstrated to meet specifications.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 212.70(e)FDA cite ID 17886 When 30 hour rule is exceeded 1Read ▾
FDA’s wording
A sample for sterility testing was held longer than 30 hours, but you did not demonstrate that the longer period did not adversely affect the sample and that the test results obtained were equivalent to test results that would have been obtained if the test had been started within the 30 hour period.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 361.1(c)(2)FDA cite ID 17964 RDRC did not meet at least once each quarter 1Read ▾
FDA’s wording
The RDRC did not meet at least once each quarter in which research activity was authorized or conducted.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 361.1(d)(5)FDA cite ID 17978 Obtaining informed consent 1Read ▾
FDA’s wording
The RDRC did not assure that the responsible investigator obtained the informed consent of human subjects or their legally authorized representative in the research study.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 361.1(d)(6)FDA cite ID 17983 Radioactive drug - chemical standard 1Read ▾
FDA’s wording
The RDRC did not [consider] [assure] that the radioactive drug used in a research study met the appropriate chemical standard of [identity] [strength] [quality] [purity] as needed for safety and to be of such uniform and reproducible quality as to give significance to the research study conducted.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 361.1(d)(6)FDA cite ID 17984 Radioactive materials for parenteral use - preparation 1Read ▾
FDA’s wording
The RDRC did not determine that radioactive materials for parenteral use were prepared in [sterile] [pyrogen-free] form.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 361.1(f)(1)FDA cite ID 17993 Packaging, labeling - Rx only 1Read ▾
FDA’s wording
The label of a radioactive drug prepared, packaged, distributed, and primarily intended for use in the RDRC research project did not bear the statement "Rx only".
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 314.80(f)(4)FDA cite ID 18028 Incomplete initial reporter information on ICSR 1Read ▾
FDA’s wording
You submitted an ICSR reporting initial reporter information that failed to include the [name] [address] [telephone number] [whether initial reporter is health care professional] [occupation of health care professional].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 FDCA 501(a)(2)(A)FDA cite ID 18943 Personnel in aseptic processing, non-sterile gloves 1Read ▾
FDA’s wording
Personnel engaged in aseptic processing were observed wearing non-sterile gloves.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 FDCA 501(a)(2)(A)FDA cite ID 18951 Personnel contact outside ISO 5 area 1Read ▾
FDA’s wording
Personnel were observed touching equipment or other surfaces located outside of the ISO 5 area with gloved hands and then proceeding with aseptic processing without changing or sanitizing gloves.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 FDCA 501(a)(2)(A)FDA cite ID 18959 Location, ISO 5 classified area 1Read ▾
FDA’s wording
The ISO 5 classified area is located within a non-classified room.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 FDCA 501(a)(2)(A)FDA cite ID 18967 Final/intermediate container and closure, sterile drug product 1Read ▾
FDA’s wording
The [final] [intermediate] containers/closures used for drug product intended to be sterile have not been sterilized or depyrogenated.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.110(b)FDA cite ID 21295 In-process conformity - examination, sample testing 1Read ▾
FDA’s wording
Your examination and testing of samples did not assure that the drug product and in-process material conformed to specifications.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 211.186(a)FDA cite ID 21296 Master production and control records, batch uniformity 1Read ▾
FDA’s wording
Your master production and control records for each drug product were not [prepared, dated, and signed by one person] [independently checked, dated, and signed by a second person].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 FDCA 505-1(f)(3)(E)FDA cite ID 21358 Failure to comply with REMS Elements to Assure Safe Use (ETASU) E 1Read ▾
FDA’s wording
An application holder did not instruct healthcare providers or health care facilities to monitor patients after administration of the drug, as required by your approved REMS Element to Assure Safe Use (ETASU) E.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 21 CFR 212.40(a)FDA cite ID 21374 Written procedures for control of components, containers, and closures 1Read ▾
FDA’s wording
You did not [establish] [maintain] [follow] written procedures describing the [receipt] [login] [identification] [storage] [handling] [testing] [acceptance and/or rejection] of [components] [drug product containers] [closures].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 FDCA 501(a)(2)(A)FDA cite ID 22731 Vermin, production area/adjacent areas 1Read ▾
FDA’s wording
Vermin or other animals or evidence of their presence was observed in the [production area] [areas adjacent to production areas].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 FDCA 501(b)FDA cite ID 22734 Releasing drug products, fail to meet established specifications 1Read ▾
FDA’s wording
Your firm released drug product in which the strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 FDCA 501(a)(2)(A)FDA cite ID 22736 Use of non-pharmaceutical, ingredients/processing aides 1Read ▾
FDA’s wording
Use of [ingredients] [processing aides] not intended for pharmaceutical use in non-sterile drug production.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 FDCA 501(a)(2)(A)FDA cite ID 22738 Use of non-pharmaceutical, ingredients/processing aides 1Read ▾
FDA’s wording
Use of [ingredients] [processing aides] not intended for pharmaceutical use in sterile drug production.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 FDCA 501(a)(2)(A)FDA cite ID 22740 Personnel infrequently, changed/sanitized gloves 1Read ▾
FDA’s wording
Personnel infrequently [changed] [sanitized] gloves to prevent contamination.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 FDCA 501(a)(2)(A)FDA cite ID 22743 Personnel moving quickly, disrupting unidirectional airflow 1Read ▾
FDA’s wording
Personnel were observed moving quickly in a critical area or in an area immediately adjacent to a critical area likely causing disruption of unidirectional airflow.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 FDCA 501(a)(2)(A)FDA cite ID 22744 Personnel, blocked or disrupted first air 1Read ▾
FDA’s wording
Personnel were observed conducting aseptic manipulations where the movement of "first air" in the ISO 5 area is blocked or disrupted.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 FDCA 501(a)(2)(A)FDA cite ID 22747 Microbial contamination was present, ISO 5/areas adjacent 1Read ▾
FDA’s wording
Microbial contamination was present in the [ISO 5 area] [areas adjacent to production areas].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 FDCA 501(a)(2)(A)FDA cite ID 22754 Water sources, present in ISO 5/adjacent area 1Read ▾
FDA’s wording
The [water sources] [sinks] [drains] are present [in the ISO 5 area] [directly adjacent to the ISO 5 area].
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 FDCA 501(a)(2)(A)FDA cite ID 22765 Lack of, routine certification of the ISO 5 1Read ▾
FDA’s wording
Lack of routine certification of the ISO 5 area.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 FDCA 501(a)(2)(A)FDA cite ID 22771 Biological indicators, not used 1Read ▾
FDA’s wording
Biological indicators were not used to verify the adequacy of the sterilization cycle.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →210 FDCA 501(a)(2)(A)FDA cite ID 22772 Lyophilizers, inadequately or not sterilized 1Read ▾
FDA’s wording
Use of lyophilizers that are [not] [inadequately] sterilized by routine sterilization cycles and protected from contamination by sterilizing filters on vacuum break air lines/vents.
CW
Does one of your recent decisions touch this area? See whether its record shows who decided, on what evidence, and why.
Test a decision like this — free assessment →No citation in FDA’s FY2025 drug data matches that search. This page covers FY2025 only.
How this page is built
What comes from FDA, and what comes from us.
Our grouping, labeled as ours
The decision areas and investigator questions are ComplianceWorxs’s own grouping. A citation is grouped only when FDA’s wording names the decision. FDA does not assign citations to decision areas.
What this page does not do
This page reports FDA’s data. It does not interpret regulations or give regulatory advice. Questions about what a regulation requires belong with your regulatory counsel.
FDA’s note on this data: the table “does not represent the complete set of 483’s issued during the fiscal year as some 483’s were manually prepared and not available in this format.” A Form 483 is not a final agency determination.
Could your last decision answer the investigator’s next question?
Pick one completed decision and see which question its record can’t answer yet. Free, about three minutes.
Take the free assessment →Already holding a Form 483?
Work out which decision the observation is testing and plan the response window.
Plan your response →ComplianceWorxs organizes the record behind a decision. It does not provide regulatory or legal advice, and it does not make, approve or recommend regulated decisions.