Ms. Gulten Erdemir
General Manager
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil
Aydinli Sb Mah, 6 Sok N 12
34953 Tuzla / İstanbul
TurkeyFEI 3010166780Issued Feb 13, 2023Center for Drug Evaluation and Research | CDER
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 3010166780.
Violations4
Issue DateFeb 13, 2023
Product TypeDrugs
StatusOpen
Letter Details
Firm
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil
Location
Ms. Gulten Erdemir
General Manager
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil
Aydinli Sb Mah, 6 Sok N 12
34953 Tuzla / İstanbul
Turkey
FEI Number
3010166780
Country
United States
Issue Date
February 13, 2023
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Drugs
Status
Open
Summary
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil, a Turkish pharmaceutical manufacturer, failed to comply with Current Good Manufacturing Practice (CGMP) regulations for finished drugs, rendering their products adulterated. During a September 2022 inspection, the FDA identified critical violations including failure to test incoming components for identity and conformity with specifications, inadequate supplier qualification, and failure to validate suppliers' test analyses at appropriate intervals. The company's October 2022 response to the inspection findings was deemed inadequate as it lacked sufficient detail and evidence of corrective actions necessary to achieve compliance.
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil FDA Warning Letter, February 13, 2023
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