FDA WARNING_LETTER - Kardesler Ucan Yaglar Sanayi Anonim Sirketi - January 21, 2025

The FDA issued a Warning Letter to Kardesler Ucan Yaglar Sanayi Anonim Sirketi, FEI 3012634391, a Turkish manufacturer of OTC drug products, following a review of records submitted under section 704(a)(4) of the FD&C Act. The letter, dated January 21, 2025, identifies significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to conduct identity testing for components (21 CFR 211.84(d)(1)):** The firm did not adequately test incoming glycerin and propylene glycol for diethylene glycol (DEG) and ethylene glycol (EG) contamination, nor did they test incoming ethanol for methanol, both of which have caused lethal poisoning incidents. 2. **Failure to test finished drug products (21 CFR 211.165(a)):** The firm did not demonstrate adequate testing of finished drug products for identity and strength of active ingredients, such as ethanol or benzalkonium chloride, prior to release. 3. **Inadequate Quality Control Unit (21 CFR 211.22(a)):** The Quality Unit (QU) failed to effectively oversee drug manufacturing operations, specifically in