Generated Documents
FDA wrote to a firm that used a generated-text tool to create specifications, procedures and master production records. The letter does not ban the tool. It says the output has to be reviewed, and the record has to show that it was.
When the inspector asks who cleared this document before it was used, this is the record that answers.
Delivered after payment · private web edition and PDF
The problem
A specification, procedure or batch record was drafted with a generated-text tool, and you need to show who reviewed it and why it was accepted.
Who it is for: Heads of Quality who approve controlled documents, and QA managers who review them.
What you get
$149 One completed, clearly labeled fictional worked record showing the evidence, judgment, remaining risk and authorization behind the decision. Delivered after payment. It does not assess your own decision.
Your $149 applies toward the $497 Inspection Response Record if you later preserve a real decision.
What to do next
Get the Case FileA page from the finished record
Illustrative case. This is an excerpt of the worked record inside the Case File: a master production record for a topical solution, drafted with a generated-text tool, revision 1. The firm, document and people are fictional.
What the full Case File adds
Inside the $149 Case File
Try three questions. See how the worked record answers each one.
The setup · public record
FDA Warning Letter 320-26-58 (April 2, 2026) records that a firm used a generated-text tool to create drug product specifications, procedures and master production records. The firm told investigators it was not aware process validation was required, because the tool “never told you it was required.” FDA cited 21 CFR 211.22(c). Here is what a clearance record would have said.
In the inspector’s chair
The inspector asks
“What was this document checked against before it was used?”
From the record’s Evidence Reviewed
Line-by-line comparison of 38 steps and acceptance limits against the approved sources: 34 matched, 4 differed. The four differences were corrected and retained.
The generated draft, revision 1, and the instruction given to the tool, retained as received.
Why it matters. It names the sources, shows what differed, and keeps the draft as received. The record does not say “reviewed”; it says against what.
The inspector asks
“What did the draft not tell you, and who looked for it?”
From the record’s Judgment
The draft was accurate on most of its steps, but accuracy was not the basis for clearance. The checklist showed a requirement the draft did not mention at all.
The absence of a validation plan in the draft was treated as a gap to close, not as a sign that none was needed. The reviewer did not rely on the tool to say what the regulation requires.
Why it matters. This is the question the firm in the letter could not answer. The checklist was written first, so silence showed up as a gap.
The inspector asks
“Who cleared this document, and under what authority?”
From the record’s Authorization
I determined that master production record MPR-0426-007, revision 1, as corrected, is accurate and complete against the checklist, and I clear it for use. The open items are accepted with the owners and dates shown.
Priya N. · Head of Quality
October 9, 2026 · 3:40 PM
Why it matters. A name, an authority, a timestamp, one document and one revision. A clearance for revision 1 does not carry over to revision 2.
The public case behind the example
FDA Warning Letter 320-26-58 (MARCS-CMS 722591) to Purolea Cosmetics Lab, dated April 2, 2026, concerns specifications, procedures and master production or control records created with a generated-text tool, and the review those documents required. The Case File keeps the public letter separate from a fictional worked example showing how the basis for clearance can be preserved.
“If you use AI as an aid in document creation, you must review the AI generated documents to ensure they were accurate and actually compliant with CGMP. Your failure to do so is a violation of 21 CFR 211.22(c).”FDA Warning Letter 320-26-58, April 2, 2026 · Read the letter on FDA.gov
Listen
Samantha and Alex examine an FDA warning letter citing AI misuse as a CGMP deficiency, and what it means for any document a tool drafts.
4 minutes 16 seconds
Get the Case File
From the sources checked and the changes made, to the risks left open and the person who authorized it. Includes the public-case analysis, the complete fictional worked example, and a six-question check for your own generated documents.
Private web edition and PDF, delivered after payment. Educational example, not a regulator-approved template or a record of your organization’s decision.
Have an actual decision to document? The Inspection Response Record — $497 → Your $149 applies.
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