FDA WARNING_LETTER - Cerci Kozmetik Ve Otel Ekipmanlari Pazarlama Ic Ve Dis Ticaret Limited Sirketi - November 21, 2023

The FDA issued a Warning Letter to Cerci Kozmetik Ve Otel Ekipmanlari Pazarlama Ic Ve Dis Ticaret Limited Sirketi, FEI 3017978054, in Istanbul, Turkey, following a review of records submitted in response to Section 704(a)(4) requests from June 16, 2022, and July 6, 2023. The facility is registered as an OTC drug product manufacturer.

The FDA found significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations include: 1. **Failure to test drug products prior to release (21 CFR 211.165(a)):** The firm distributed an OTC drug product without adequate finished product testing, specifically lacking identity and strength testing of the active ingredient on the Certificate of Analysis (COA). The FDA requires an action plan and timelines for full chemical and microbiological testing of retain samples for all U.S.-distributed drug products within expiry, and a summary of results, with rapid corrective actions if substandard. 2. **Failure to establish an adequate stability testing program (21 CFR 211.166(a)):** The firm did not demonstrate that chemical properties remain acceptable throughout the 24-month expiry period.