Sudesan Temizlik Urunleri Ve Ambalaj Sanaryi Ticaret Anomin Sirketi

Warning LetterOpen

Mr. Kemal Deniz Sudesan Temizlik Urunleri Ve Ambalaj Sanaryi Ticaret Anomin Sirketi No:5 Petrol Ofisi Caddesi Sehit Komando Onbasi Ugur Hanci Sokak 34310 Avcilar / İstanbul Turkey kdeniz@sudesan.comFEI 3004647124Issued Nov 13, 2023Center for Drug Evaluation and Research | CDER

View Letter

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 3004647124.

Violations4

Issue DateNov 13, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Sudesan Temizlik Urunleri Ve Ambalaj Sanaryi Ticaret Anomin Sirketi
Location: Mr. Kemal Deniz Sudesan Temizlik Urunleri Ve Ambalaj Sanaryi Ticaret Anomin Sirketi No:5 Petrol Ofisi Caddesi Sehit Komando Onbasi Ugur Hanci Sokak 34310 Avcilar / İstanbul Turkey kdeniz@sudesan.com
FEI Number: 3004647124
Country: United States
Issue Date: November 13, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Sudesan Temizlik Urunleri Ve Ambalaj Sanaryi Ticaret Anomin Sirketi, a Turkish manufacturer of over-the-counter hand sanitizer products, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The company failed to conduct identity testing on incoming drug components and did not validate or establish the reliability of its component suppliers' test analyses at appropriate intervals, as required by 21 CFR 211.84(d)(1) and 211.84(d)(2). These deficiencies rendered the firm's sanitizer drug products adulterated under the Federal Food, Drug, and Cosmetic Act.

Sudesan Temizlik Urunleri Ve Ambalaj Sanaryi Ticaret Anomin Sirketi FDA Warning Letter, November 13, 2023