FDA issued a Warning Letter to Purolea Cosmetics Lab that includes a dedicated section on AI use in cGMP. FDA states the firm used AI agents to create drug product specifications, procedures, and master production/control records. FDA’s key message is that AI-generated documents must be reviewed by humans (Quality Unit responsibility) and that “overreliance” on AI is unacceptable (including the firm stating it didn’t perform process validation because the AI “never told them” it was required).
Why it matters for pharma: This is a clear enforcement signal: AI can be used as a drafting aid, but it cannot replace QMS responsibilities (review/approval, validation, compliance checks, documented oversight).
Primary source (FDA Warning Letter): https://www.fda.gov/ … -lab-722591-04022026