Mr. Ali Kaya
Vice General Manager
Gulsah Uretim Kozmetik Sanayi Anonim Sirketi
No: 6 Omerli Mahallesi Arnavutkoy
/ İstanbul
TurkeyFEI 3010734749Issued May 13, 2021Center 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 3010734749.
Violations4
Issue DateMay 13, 2021
Product TypeDrugs
StatusOpen
Letter Details
Firm
Gulsah Uretim Kozmetik Sanayi Anonim Sirketi
Location
Mr. Ali Kaya
Vice General Manager
Gulsah Uretim Kozmetik Sanayi Anonim Sirketi
No: 6 Omerli Mahallesi Arnavutkoy
/ İstanbul
Turkey
FEI Number
3010734749
Country
Turkey
Issue Date
May 13, 2021
Issuing Office
Center for Drug Evaluation and Research | CDER
Product Type
Drugs
Status
Open
Summary
Gulsah Uretim Kozmetik Sanayi Anonim Sirketi, a Turkish manufacturer of over-the-counter drug products, violated current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. The company failed to conduct adequate laboratory testing to confirm the identity and strength of active ingredients in drug batches prior to release for distribution to the U.S. market, in violation of 21 CFR 211.165(a). During FDA inquiries in July 2020 and January 2021, the company acknowledged that it did not perform required identity and strength testing for active pharmaceutical ingredients before releasing batches, rendering their drug products adulterated.
Gulsah Uretim Kozmetik Sanayi Anonim Sirketi FDA Warning Letter, May 13, 2021
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