FDA warns firm for inappropriate use of AI in drug manufacturing

The US Food and Drug Administration (FDA) has issued a warning letter to Purolea Cosmetics Lab for several violations of Good Manufacturing Practices (GMP). Notably, the warning letter calls the company out for excessive reliance on artificial intelligence (AI) to create drug specifications, procedures, and production records, without adequate quality control oversight.

An attorney who spoke to Focus noted that this action does not mean the agency is against AI; rather, it emphasizes that manufacturers should not depend on AI without a proper understanding of GMPs.

The warning letter to the Livonia, MI-based company followed a three-day inspection in late October. The company produces homeopathic drug products, including “Dermveda Extra Strength Shingles Relief” and “Dermveda Extra Strength Ultra Genital Herpes Relief.”

The overarching theme of the warning letter was the company’s lack of basic understanding of GMPs and was relying instead on AI to substitute this knowledge.

FDA said the company's quality control unit did not ensure that its drug products complied with GMPs. For instance, the quality control unit under 21 CFR 211.22 failed to make sure that established procedures were followed, that batch records were reviewed prior to product release, and that adequate production and process controls were put in place.

Additionally, the FDA cited the company’s quality control unit under 21 CFR 21.22(c) for its “inappropriate use” of AI in pharmaceutical manufacturing. Company officials explained to the FDA that they used AI to help the firm adhere to FDA regulations, specifically in the creation of drug product specifications, procedures, and master control records.

This did not appease FDA. The agency said if AI is used in document creation, the firm “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).”

Another issue was the company’s excessive dependence on AI. For instance, an investigator noted that the firm had not performed process validation to ensure that its processes were under control. The firm replied that it “was not aware” of the legal requirements because AI did not inform them that this validation was needed.

Other issues included unsanitary conditions at the facility. During the inspection, an investigator observed the presence of insects, dirt, leaves, and clutter in several areas throughout the facility.

Additionally, the company did not have sufficient measures in place to prevent contamination from both internal and external sources. For instance, when the docking bay door was opened, it directly exposed the manufacturing area to the outside environment.

FDA said the company failed to conduct “appropriate laboratory testing” to ensure that products were free of objectionable microorganisms.

FDA noted that the company has stopped producing drugs at the facility.

Kalie Richardson, an attorney from Hyman, Phelps & McNamara, stated that this letter highlights fundamental GMP shortcomings and should not indicate that the agency is against the use of AI.

“I would say one takeaway I had is that I don’t get the impression that the FDA has an issue with the use of AI to draft documents. Their issue is that no one reviewed it and it was completely inaccurate. I don’t think they are saying that the use of AI is not OK. I don’t think this is what FDA is saying…. It sounds like the issues were so rudimentary. No one has any knowledge of GMPs, and no one knows enough to know what AI is telling you is wrong.”

Richardson said that manufacturers should ideally use a closed system, so they know what the inputs are and the source materials are. “I do think it is interesting that the warning letter is focused on the outputs and that the company used this to generate stuff that they don't even understand. FDA did not touch the inputs. My guess is that that were using a commercial off the shelf tool and haven’t tried to create some kind of internal system.”

Purolea warning letter