Tan Alize Kozmetik Ve Temizlik Urunleri

Warning LetterClosed

Latife Nesrin Ozdemir Product Development and Regulatory Affairs Executive Tan Alize Kozmetik Ve Temizlik Urunleri Sanayi Ve Ticaret Anonim Sirketi No. 32 Omerli Mahallesi Uran Caddesi 34799 Cekmekoy / İstanbul Turkey Nesrin.Ozdemir@farmasi.com.trFEI 3004135088Issued Aug 3, 2023Center for Drug Evaluation and Research | CDER

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Letter Details

Firm: Tan Alize Kozmetik Ve Temizlik Urunleri
Location: Latife Nesrin Ozdemir Product Development and Regulatory Affairs Executive Tan Alize Kozmetik Ve Temizlik Urunleri Sanayi Ve Ticaret Anonim Sirketi No. 32 Omerli Mahallesi Uran Caddesi 34799 Cekmekoy / İstanbul Turkey Nesrin.Ozdemir@farmasi.com.tr
FEI Number: 3004135088
Country: United States
Issue Date: August 03, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Closed
Closeout Letter: August 30, 2024

Summary

Tan Alize Kozmetik Ve Temizlik Urunleri, a Turkish manufacturer of over-the-counter drug products including sunscreens, failed to conduct required identity testing on incoming components at high risk of contamination with diethylene glycol (DEG) or ethylene glycol (EG), specifically for glycerin and other ingredients used in their drug formulations. The company's manufacturing methods, facilities, and controls did not conform to Current Good Manufacturing Practice (CGMP) regulations under 21 CFR parts 210 and 211, resulting in adulterated drug products. The FDA identified significant violations of 21 CFR 211.84(d)(1), which requires testing to verify the identity of each component in a drug product.

Tan Alize Kozmetik Ve Temizlik Urunleri FDA Warning Letter, August 3, 2023