Bioequivalence and Bioavailability Forum

Dear all,

I could not resist. Funny and crazy: Warning Letter 320-26-58

[…] failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality.

IMHO, testing for strength of a homeopathic ‘drug’ is very, very difficult.

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.

Human stupidity is already bad enough. We shouldn’t add another artificial layer below that.