Kardesler Ucan Yaglar Sanayi Anonim Sirketi — FDA Warning Letter Findings

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)). The records and information you provided did not demonstrate that your quality unit (QU) effectively exercised its responsibilities to oversee the quality of your drug manufacturing operations. For example, your QU…

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)). You manufacture OTC drug products such as hand sanitizing wipes. Based on the records and information you provided, you did not demonstrate that you adequately tested the identity of incoming components used in the manufacture of your drug products. Glycerin & Propylene Glycol Information provided indicated that you failed to adequately test each…

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)). Based on the records and information you provided, you did not demonstrate that you adequately tested your drug products for the identity and strength of the active ingredients prior to release and distribution. For example, your responses did not demonstrate that you tested the identity or strength of ethanol or benzalkonium chloride in your finished drug products. Testing is an essential part of CGMP to ensure that the drug products you manufacture conform to all pre-determined quality attributes appropriate for their intended use. Drug products must be tested for identity and strength of the active ingredient, prior to release and distribution. Without adequate testing, you do not have scientific evidence to assure that your drug products conform to appropriate specifications before release.