FDA Issues First Warning Letter Addressing AI-Generated Drug Specifications and Master Production Records

FDA issues a Warning Letter addressing “the use of AI in creating the drug product specifications, procedures, and master production or control records”

The FDA recently issued a warning letter to a US pharma company that had many FDA cGMP issues. This is the first time we have seen the FDA use a warning letter to address the use of AI by the company to create the product specifications, procedures and the master production or control records.

The warning letter was issued in April 2026 to a company in Michigan.

What Triggers an FDA Warning Letter After a Form 483

Please remember that the FDA issues a warning letter after a facility inspection resulting in an extensive Form-483 that documents critical observations that in FDA’s opinion affect how the company operates and assures the quality of the products they manufacture. In this case, the company also had issues with the their product was previously approved.

Why the Company’s 483 Response Was Found Inadequate

After the issuance of the 483, the company is supposed to provide a written response back to FDA showing their corrective actions. The inspected company in Michigan submitted their response to the Agency. However, FDA found the response to be inadequate because the company failed to provide supportive documentation or adequate evidence of corrective actions taken to bring their operations into compliance with CGMP.

What an Adequate 483 Response Must Include

It is important to understand that for a 483 response to be considered adequate by FDA it must clearly show what the company intends to do to bring operations into compliance and provide evidence of completed actions or a time frame when these actions will be accomplished. An adequate 483 response can prevent FDA from escalating further regulatory actions such as a warning letter.

While the company in this example had various cGMP issues, the one we want to focus on now was related to the use of AI.

Inappropriate Use of Artificial Intelligence in Pharmaceutical Manufacturing

In the warning letter, FDA stated the following:

 “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”.

Human Review Requirements When AI Supports cGMP Activities

This warning letter shows what the FDA is expecting from the companies that are generating their documents via AI. You cannot just expect that since AI is doing all the work, the resulting documents are acceptable and ok with the FDA. As with any computer generated documents or procedures, qualified company personnel must validate the information. You cannot accept the AI generated documentation as a fact without validating it.

For more information on what is expected during an FDA inspection, and/or if you have any questions about FDA inspections or AI expectations please contact us at:

Info@mdiconsultants.com and RE: FDA inspections, 483, Warning letters and/or AI