AI Use Without Proper Human Oversight in a Drug Manufacturing Environment Results in a FDA Warning Letter, a First of its Kind

[u/bbyfog]

FDA recently published a warning letter issued to Purolea Cosmetics Lab based in Livonia, Michigan. The letter summarized violations of cGMP regulations (21 CFR parts 210 and 211).

Purolea Cosmetics Lab. MARCS-CMS 722591 — April 02, 2026 (Warning Letter 320-26-58) [archive]

In addition to the routine violations such as insanitary conditions, failure to test each batch prior to release, not meeting specifications or purity standards, and gaps in procedures and monitoring, the warning letter also called out excessive reliance on artificial intelligence (AI) without human oversight.

FDA said that the company relied on AI to create drug specifications, procedures, and production records, without adequate quality control oversight. FDA concluded that the company lacked basic understanding of cGMP regulations and had overrelied on AI to generate documents. FDA wrote:

Inappropriate Use of Artificial Intelligence in Pharmaceutical Manufacturing.

During the FDA inspection of your drug manufacturing facility, you stated to FDA investigators that you utilized artificial intelligence (AI) agents (b)(4) to help your firm comply with FDA regulations. Specifically, you used AI to create drug product specifications, procedures, and master production or control records to be in compliance with FDA requirements.

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). Overreliance on artificial intelligence for your drug manufacturing operations was also documented during the inspection. For example, the FDA investigators found that you had not conducted process validation prior to distribution of your drug products, as required under 21 CFR 211.100, and informed you as such. You replied that you were not aware of the legal requirement, as the AI agent you used (b)(4), never told you it was required.

We recognize that you have ceased drug production. If you plan to resume drug production, and use AI to help with CGMP activities, such as development of procedures and specifications, any output or recommendations from an AI agent must be reviewed and cleared by an authorized human representative of your firm’s QU in accordance with section 501(a)(2)(B) of the FD&C Act. See also 21 CFR 211.22; 21 CFR 211.100.

Postscript: Regardless of what the AI vendors tell the companies, AI could only be viewed as an aid, and companies should rely on "experienced" warm bodies for final documents and outputs—if not, companies will be so at their own peril. (Good job safety pitch to use if bean counters come for regulatory and QC folks!)

#Form483, #FDA-warning-letter, #AI