FDA WARNING_LETTER - Purolea Cosmetics Lab - October 30, 2025

The FDA issued a warning letter to Purolea Cosmetics Lab following an inspection from October 28 to 30, 2025, at its Michigan facility. The investigation revealed that the company’s drug products were manufactured under insanitary conditions, including the presence of insects and filth, and failed to meet Current Good Manufacturing Practice (CGMP) standards. Key violations involved a lack of microbiological testing for finished batches and the failure to verify the identity and purity of raw materials, creating risks of contamination. Notably, the firm inappropriately relied on artificial intelligence to generate manufacturing procedures and specifications without human oversight or validation, resulting in a failure to meet legal production standards. Furthermore, Purolea marketed products for shingles and genital herpes that are classified as unapproved new drugs under the Federal Food, Drug, and Cosmetic Act. While the company has ceased production, the FDA requires immediate action to account for products still in distribution. Required steps include identifying all discontinued drugs by National Drug Code, clarifying plans for remaining market inventory, and updating registration status. Should the firm decide to resume operations, it must hire a qualified consultant, undergo a comprehensive six-system audit, and implement human review for all AI-generated compliance documents to ensure accuracy and regulatory adherence.