Cerci Kozmetik Ve Otel Ekipmanlari Pazarlama Ic Ve Dis Ticaret Limited Sirketi Warning Letter Details

Summary

Cerci Kozmetik Ve Otel Ekipmanlari Pazarlama Ic Ve Dis Ticaret Limited Sirketi, a Turkish OTC drug manufacturer, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The company failed to conduct appropriate laboratory testing to confirm that each drug batch met final specifications for identity and strength of active ingredients prior to product release, as required by 21 CFR 211.165(a). This manufacturing deficiency resulted in the company's drug products being deemed adulterated, prompting FDA enforcement action in November 2023 following the company's responses to records requests issued in June 2022 and July 2023.