Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil – FDA Warning Letter, Sep 16, 2022

On February 13, 2023, the FDA issued a Warning Letter to Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil, following an inspection from September 12-16, 2022, at their Istanbul, Turkey facility. The inspection revealed 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 test components:** The firm did not adequately test incoming components for identity, purity, strength, and quality, nor did they validate supplier test analyses (21 CFR 211.84(d)(1) and 211.84(d)(2)). 2. **Inadequate production and process controls:** The firm failed to establish validated processes for drug product manufacturing, lacking appropriate testing (e.g., assay testing) and equipment qualification (21 CFR 211.100(a)). 3. **Insufficient stability testing program:** The firm lacked an adequate written program to assess drug product stability, including testing for active ingredients and impurities, to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).

The FDA deemed the firm's October 7, 2022, response to the Form FDA 4