Saruhan Kimya Ve Temizlik Urunleri Sanayi Ticaret Anonim Sirketi Corlu Subesi

Warning LetterOpen

Mr. Suleyman Kutluay Saruhan Kimya Ve Temizlik Urunleri Sanayi Ticaret Anonim Sirketi Corlu Subesi No: 33-1 Velimese Osb Mahallesi 233 Sokak, E 59930 / Tekirdağ TurkeyFEI 3018310083Issued Nov 6, 2023Center for Drug Evaluation and Research | CDER

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Violations4

Issue DateNov 6, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Saruhan Kimya Ve Temizlik Urunleri Sanayi Ticaret Anonim Sirketi Corlu Subesi
Location: Mr. Suleyman Kutluay Saruhan Kimya Ve Temizlik Urunleri Sanayi Ticaret Anonim Sirketi Corlu Subesi No: 33-1 Velimese Osb Mahallesi 233 Sokak, E 59930 / Tekirdağ Turkey
FEI Number: 3018310083
Country: Turkey
Issue Date: November 06, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Saruhan Kimya Ve Temizlik Urunleri Sanayi Ticaret Anonim Sirketi Corlu Subesi, a Turkish manufacturer of over-the-counter drug products, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their products adulterated. The company failed to conduct required identity testing on incoming drug components and did not validate or establish the reliability of their component suppliers' test analyses at appropriate intervals, as required by 21 CFR 211.84(d)(1) and 211.84(d)(2). These violations were identified following FDA review of records submitted in response to three separate information requests between June 2022 and July 2023.

Saruhan Kimya Ve Temizlik Urunleri Sanayi Ticaret Anonim Sirketi Corlu Subesi FDA Warning Letter, November 6, 2023