Ms. Elif M. Diri
CEO and Owner
Diora Kimya Sanayi ve Ticaret Limited Sirketi
Baspinar Osb 2 Bolge, Street No: 26
Mahallesi, 83226 Nolu Caddesi
27500 Sehitkamil / Gaziantep
TurkeyFEI 3013927966Issued Oct 17, 2024Center 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 3013927966.
Violations5
Issue DateOct 17, 2024
Product TypeDrugs
StatusOpen
Letter Details
Firm
Diora Kimya Sanayi ve Ticaret Limited Sirketi
Location
Ms. Elif M. Diri
CEO and Owner
Diora Kimya Sanayi ve Ticaret Limited Sirketi
Baspinar Osb 2 Bolge, Street No: 26
Mahallesi, 83226 Nolu Caddesi
27500 Sehitkamil / Gaziantep
Turkey
FEI Number
3013927966
Country
Turkey
Issue Date
October 17, 2024
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Diora Kimya Sanayi ve Ticaret Limited Sirketi, a Turkish drug manufacturer, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of finished pharmaceuticals, including failure to conduct identity tests on drug components and failure to validate supplier test analyses as required by 21 CFR 211.84(d)(1). The company's Personal CARE Antibacterial Soap product (NDC 72133-049) was found to be adulterated and misbranded because it was not duly listed with the FDA as required by section 510(j) of the Federal Food, Drug, and Cosmetic Act. These compliance failures rendered the drug product unsuitable for interstate commerce and subject to enforcement action.
Diora Kimya Sanayi ve Ticaret Limited Sirketi FDA Warning Letter, October 17, 2024
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