Inspection Scenario Library
FDA Inspection Scenarios From Pharmaceutical
and Biotech Inspections
An FDA investigator often asks one question during inspections: who authorized the decision — and what evidence did they review before making it. The scenarios below reconstruct real inspection moments where that authorization record could not be produced.
Most Referenced Scenarios
Who Authorized This Batch Release?
"Who authorized this batch release, and what evidence did they review before making that decision?"
View scenario →Who Authorized This CAPA Closure?
"Who made the determination that this CAPA was effective, and what evidence supported that conclusion?"
View scenario →Who Authorized the Deviation Disposition?
"Who made the disposition decision for this deviation, and what evidence did they review?"
View scenario →Batch Release · Deviation · OOS · Material Rejection
Product Disposition Decisions
Who Authorized This Batch Release?
"Who authorized this batch release, and what evidence did they review before making that decision?"
Who Authorized the Deviation Disposition?
"Who made the disposition decision for this deviation, and what evidence did they review?"
Who Authorized the OOS Investigation Conclusion?
"Who made the final determination that this OOS result was assignable, and what was the basis?"
Who Authorized the Stability Data Acceptance?
"Who made the determination that this stability data supported the claimed shelf life, and what was the basis?"
Who Authorized the Environmental Monitoring Excursion Decision?
"Who made the determination that this environmental excursion did not affect product quality, and what was the basis?"
Who Authorized the Material Rejection Decision?
"Who made the decision to reject this incoming material, and what was the regulatory basis for that determination?"
Who Authorized the Retest Period Extension?
"Who made the determination that the stability data supported extending the retest period, and what was the regulatory basis?"
CAPA · Root Cause · Complaint · Periodic Review
Investigation Closure Decisions
Who Authorized This CAPA Closure?
"Who made the determination that this CAPA was effective, and what evidence supported that conclusion?"
Who Authorized the Periodic Review Conclusion?
"Who made the determination that this system remained in a state of control, and what evidence supported that conclusion?"
Who Authorized the Root Cause Determination?
"Who made the decision that this was the root cause, and what evidence was used to reach that conclusion?"
Who Authorized the Complaint Investigation Closure?
"Who made the determination that this complaint investigation was complete and that no further action was required?"
Change Control · Validation · Supplier · Data Integrity
Regulatory Impact Decisions
Who Approved This Change Control?
"Who made the regulatory impact determination for this change, and what was the basis for that assessment?"
Who Authorized This Supplier Qualification?
"Who made the qualification decision for this supplier, and what was the basis for that determination?"
Who Authorized the Validation Protocol Deviation?
"Who made the decision to accept this protocol deviation, and what was the scientific and regulatory basis?"
Who Authorized the Data Integrity Exception?
"Who made the determination that this data integrity exception did not compromise the reliability of your records?"
Who Authorized the Process Validation Conclusion?
"Who made the determination that this process was validated, and what evidence supported that conclusion?"
Who Authorized This Computerized System Validation?
"Who made the determination that this system was validated for its intended use, and what was the regulatory basis?"
Who Authorized the Cleaning Validation Acceptance?
"Who made the determination that your cleaning validation data supported the claimed cleaning effectiveness?"
Who Authorized This Risk Assessment?
"Who made the determination that the risk level assigned was appropriate, and what evidence was used?"
Who Authorized the Specification Change?
"Who made the determination that this specification change was scientifically justified and regulatorily acceptable?"
Related inspection intelligence
These scenarios are part of a connected inspection intelligence system. Investigators follow predictable lines of inquiry — from observation to question to authorization gap.
Authorization Assessment
Could your team answer these questions
during an inspection?
Most organizations can reconstruct the answer after the fact.
Investigators expect the answer to already exist in the record.
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