← The Record Behind the Decision
Episode 1 · The AI Never Told Us · 4 min 16 sec
The AI Never Told Us
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.
With Samantha and Alex ·
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“Our team used a tool to draft a procedure. What would show someone reviewed it before it was used?”
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Examine the decision
Purolea Case File
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.
Examine the Case File — $149The decision
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 letter states: “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).”
Sources
Further reading
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Article · 8 min read
A tool drafted the document. Who cleared it for use, and against what?
FDA has told a manufacturer in writing that documents a tool drafted must be reviewed and cleared by the quality unit. The review that matters is the one that can find what the draft never says, and the record has to show it happened.
Read the article -
Article · 7 min read
Manufacturing intelligence: who is accountable for the decisions it shapes?
A generated answer is not a basis for action. The organization has to explain why relying on it was reasonable.
Read the article -
Next episode · Episode 2
CAPA Effectiveness: Two Warning Letters, One Failure
Samantha and Alex examine two November FDA warning letters and what makes a CAPA record hold up — the shared quality-unit failure, the CAPA pattern, and the six questions a CAPA record has to answer.
Listen · 20 min 7 sec