FDA WARNING_LETTER - Patcos Cosmetics Pvt. Ltd. - July 18, 2025

The FDA issued a Warning Letter to Patcos Cosmetics Pvt. Ltd. on March 12, 2026, following an inspection from July 14-18, 2025, at their drug manufacturing facility in Daman, India. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations, rendering their over-the-counter (OTC) drug products adulterated under sections 501(a)(2)(A) and 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key issues included pervasive insanitary conditions, such as broken windows, harborage areas, and water damage in production and storage zones. The company failed to maintain its facility in good repair, a recurring issue from a 2017 inspection. Critical failures in quality control involved inadequate identity testing for high-risk components, particularly regarding diethylene glycol (DEG) contamination, despite previous commitments. Production processes lacked validation, and the water system was inadequately designed and maintained, leading to issues like super potent drug batches.

Moreover, the firm"s Quality Unit was ineffective, failing to ensure data integrity, complete records, adequate specifications, or stability testing. The FDA strongly recommended engaging an independent third-party consultant to assist with comprehensive remediation, including a thorough investigation into data integrity lapses. Patcos Cosmetics must submit a detailed corrective action plan within 15 working days, addressing all deficiencies. The facility remains on Import Alert 66-40, preventing its drug products from entering the U.S.