Cerci Kozmetik Ve Otel Ekipmanlari Pazarlama Ic Ve Dis Ticaret Limited Sirketi

Warning LetterOpen

Mr. Ahmet Turan Aydin Cerci Kozmetik Ve Otel Ekipmanlari Pazarlama Ic Ve Dis Ticaret Limited Sirketi Aytop Sanayi Sitesi B2 Block, 14-15-16 Battalgazi Mahalle 34935 Anatolia / İstanbul TurkeyFEI 3017978054Issued Nov 16, 2023Center for Drug Evaluation and Research | CDER

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3017978054.

Violations4

Issue DateNov 16, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Cerci Kozmetik Ve Otel Ekipmanlari Pazarlama Ic Ve Dis Ticaret Limited Sirketi
Location: Mr. Ahmet Turan Aydin Cerci Kozmetik Ve Otel Ekipmanlari Pazarlama Ic Ve Dis Ticaret Limited Sirketi Aytop Sanayi Sitesi B2 Block, 14-15-16 Battalgazi Mahalle 34935 Anatolia / İstanbul Turkey
FEI Number: 3017978054
Country: Turkey
Issue Date: November 16, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

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.

Cerci Kozmetik Ve Otel Ekipmanlari Pazarlama Ic Ve Dis Ticaret Limited Sirketi FDA Warning Letter, November 16, 2023