Ms. Sezin Zavaro
Head of the Board
Kardesler Ucan Yaglar Sanayi Anonim Sirketi
Inonu Mah Gebze Plastikciler OSB
Mah 42 Sokak No:1
41400 Gebze / Kocaeli
TurkeyFEI 3012634391Issued Jan 21, 2025Center 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 3012634391.
Violations4
Issue DateJan 21, 2025
Product TypeDrugs
StatusOpen
Letter Details
Firm
Kardesler Ucan Yaglar Sanayi Anonim Sirketi
Location
Ms. Sezin Zavaro
Head of the Board
Kardesler Ucan Yaglar Sanayi Anonim Sirketi
Inonu Mah Gebze Plastikciler OSB
Mah 42 Sokak No:1
41400 Gebze / Kocaeli
Turkey
FEI Number
3012634391
Country
Turkey
Issue Date
January 21, 2025
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Kardesler Ucan Yaglar Sanayi Anonim Sirketi, a Turkish manufacturer of over-the-counter drug products including hand sanitizing wipes, failed to comply with Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The company did not conduct adequate identity testing on incoming components as required by 21 CFR 211.84(d)(1), specifically failing to test each shipment of glycerin and propylene glycol used in drug product manufacture. These violations rendered the firm's drug products adulterated under the Federal Food, Drug, and Cosmetic Act, based on FDA's review of records submitted in response to a March 2024 inspection request.
Kardesler Ucan Yaglar Sanayi Anonim Sirketi FDA Warning Letter, January 21, 2025
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