Kardesler Ucan Yaglar Sanayi Anonim Sirketi

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)).

Passage 2

You failed to demonstrate that you adequately test your incoming ethanol, used as an active ingredient, for methanol. The use of ethanol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document *Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol* to help you meet the CGMP requirements when manufacturing drugs containing ethanol at https://www.fda.gov/media/173005/download

Passage 3

Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).

Passage 4

Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).

Passage 5

Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Kardesler Ucan Yaglar Sanayi Anonim Sirketi, Inonu Mah Gebze Plastikciler OSB, Mah 42 Sokak No: 1, Gebze/Kocaeli 41400, Turkey, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission.