Tan Alize Kozmetik Ve Temizlik Urunleri – FDA Warning Letter, Aug 8, 2023

The FDA issued a Warning Letter to Tan Alize Kosmetik, a Turkish manufacturer of OTC drug products, following a review of records submitted per Section 704(a)(4) of the FD&C Act. The letter, dated August 3, 2023, identifies significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Failure to conduct identity testing for components (21 CFR 211.84(d)(1)):** The firm did not adequately test each shipment of high-risk components like glycerin for diethylene glycol (DEG) or ethylene glycol (EG) contamination using USP identification tests. This poses a significant safety risk due to the lethal poisoning incidents associated with DEG/EG. 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 across other CGMP operations.

The FDA recommends engaging a qualified CGMP consultant to evaluate operations and assist in meeting requirements, including a comprehensive six-system audit. The firm was placed on Import Alert 66-40 on June 23, 2023. Corrective actions are required within 30 working days, and failure to