Gulsah Uretim Kozmetik Sanayi Anonim Sirketi – FDA Warning Letter, Aug 31, 2021

This FDA Warning Letter (No: 320-21-46, May 13, 2021) was issued to Gulsah Uretim Kozmetik Sanayi Anonim Sirketi, FEI 3010734749, following a review of records submitted in response to an April 23, 2020, request under section 704(a)(4) of the FD&C Act. The facility, an OTC drug product manufacturer, was found to have significant violations of CGMP regulations (21 CFR parts 210 and 211), rendering its drug products adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations include: 1. **Failure to test finished drug products (21 CFR 211.165(a)):** The firm did not conduct adequate testing for identity and strength of active ingredients (e.g., (b)(4)%) prior to release for U.S. distribution, relying on claims of formulation stability without scientific evidence. 2. **Failure to test components and validate supplier analyses (21 CFR 211.84(d)(1) and (2)):** The firm did not test incoming active pharmaceutical ingredients (APIs) for identity and relied solely on vendor Certificates of Analysis (CoAs) without