Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil

Warning LetterOpen

Mr. Selim Yesil Owner Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil N.12 Istanbul Endustri Ve Ticaret Serbest Bolgesi Aydinli Sb Mahallesi, 6. Sokak 34953 Tuzla / İstanbul TurkeyFEI 3010166780Issued Jul 8, 2021Center for Drug Evaluation and Research

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 3010166780.

Violations2

Issue DateJul 8, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil
Location: Mr. Selim Yesil Owner Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil N.12 Istanbul Endustri Ve Ticaret Serbest Bolgesi Aydinli Sb Mahallesi, 6. Sokak 34953 Tuzla / İstanbul Turkey
FEI Number: 3010166780
Country: Turkey
Issue Date: July 08, 2021
Issuing Office: Center for Drug Evaluation and Research
Product Type: Drugs
Status: Open

Summary

Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil, a Turkish drug manufacturer, was cited for manufacturing an adulterated antiseptic hand rub product that contained only 59% ethanol by volume instead of the labeled concentration, failing to meet the active ingredient strength declared on the label. The product was detained at the U.S. border and FDA testing confirmed the subpotency violation under section 501(c) of the FD&C Act, indicating the company's quality assurance and Current Good Manufacturing Practice (CGMP) controls were not functioning adequately. The deficiency demonstrated systemic failures in the firm's manufacturing processes and quality oversight for this hand sanitizer product.

Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil FDA Warning Letter, July 8, 2021