FDA WARNING_LETTER - Patcos Cosmetics Pvt. Ltd. - December 15, 2023

The FDA issued a Warning Letter to Patcos Cosmetics Pvt. Ltd. (FEI 3009250196) in Mumbai, India, on December 15, 2023, following a review of records submitted in response to a July 12, 2023, request under section 704(a)(4) of the FD&C Act. The facility is registered as an OTC drug product manufacturer.

The letter identifies significant Current Good Manufacturing Practice (CGMP) violations, rendering the drug products adulterated under section 501(a)(2)(B) of the FD&C Act. Key violations include:

1. **Failure to conduct identity testing of components (21 CFR 211.84(d)(1)):** The firm did not adequately test each shipment of high-risk components like glycerin, propylene glycol, and sorbitol solution for diethylene glycol (DEG) or ethylene glycol (EG) contamination using USP identity tests. 2. **Failure to establish an adequate quality control unit (21 CFR 211.22(a)):** The Quality Unit (QU) did not effectively oversee drug manufacturing operations, specifically failing to approve or reject components in the Materials System. Concerns were raised about the QU's oversight in other CGMP areas.

The FDA recommends engaging a qualified CGMP consultant to evaluate operations and assist in meeting