FDA AI warning letter and its 1 linked instrument

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	FDA AI warning letter	21 CFR Part 211
Authority	FDA	FDA
Legal weight	Warning letter: a flag, not a rule	Law & regulation
Status	Warning letter	In force
Last verified	Not yet	Not yet
Summary	Described as FDA's first CGMP enforcement on AI misuse: the firm used AI to generate specifications and procedures without adequate review. FDA said AI-generated documents must be reviewed for accuracy.	US CGMP rules for finished pharmaceuticals. Section 211.68 allows computers and automated equipment in manufacture if they are routinely checked under a written program. It requires controls so only authorised people change master records, checks on input and output, and a backup of data.
Lifecycle	2 Apr 2026 Warning letter 320-26-58 issued (2 Apr 2026)	29 Sep 1978 Published at 43 FR 45077
Source	Official text Source: FDA. Public domain.	Official text Source: FDA. Public domain.

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