FDA Issues “Inappropriate Use of Artificial Intelligence in Pharmaceutical Manufacturing” in a Warning Letter

By Dean Cirotta, President, EAS Consulting Group

In an April 2, 2026 warning letter (WL 320-26-58), issued to Purolea Cosmetics Lab (Purolea Cosmetics Lab – 722591 – 04/02/2026 | FDA), the FDA included one of the first GMP AI related observations to the industry. In the warning letter the FDA states that:

“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.”

It is clear from the FDA’s statements that they acknowledge companies may use AI to create and generate GMP related documents, such as specifications, SOPs and even master production records. However, if a company chooses to do so, these documents must still go through a thorough review and approval process by the appropriate Quality Unit personnel prior to implementation. This is a clear requirement, per § 211.22(c) “Responsibilities of quality control unit”, which states that “The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product”. Without this “human” review and approval, AI created documents are not compliant with the GMPs. It is also clear from this situation that AI does not have the ability to assess all of the specific GMP requirements and produce fully compliant draft documents. Therefore, without appropriately trained and qualified quality personnel, who understand all the GMP requirements and who can apply that knowledge to the review and approval of the AI generated documents, there is a likelihood that companies will implement non-compliant and incomplete quality systems and documentation.

Though AI can certainly be used as a tool to assist in the development of GMP documents, it cannot and should not be used to replace the knowledge and expertise of experienced QA personnel. The GMP documents created by AI are likely only a reflection of what the AI tool references from the CFR. These documents appear to be a very generic interpretation of the regulations, and do not and cannot reflect the specific roles, responsibilities and processes within a manufacturing site or include “how” things are actually done by each individual company. In addition, it appears that the AI generated information is only a very high-level summarization of the regulations and does not include all the detailed requirements needed for compliance, such as process validation

This warning letter should serve as a notice to the industry that the FDA is aware of how AI can potentially be used by companies in developing their quality systems but that they will be confirming that, regardless of how the documents are drafted, they are still reviewed and approved by qualified human QU personnel.