Pushclean Technology Plastik Sanayi Ve Ticaret Ltd. Sirketi — FDA Warning Letter Findings

Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2). 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. Specifically, you failed to conduct identity and component testing for (b)(4) , and you failed to conduct conductivity and total organic carbon testing on your (b)(4) used to manufacture your drug products. Without adequate testing, you do not have scientific evidence that your components conform to appropriate specifications prior to use in the manufacture of your drug products.

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 demonstrate that your quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of your drug manufacturing operations. For example, your QU…

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)). Your firm manufactures OTC drug products, such as (b)(4) wipes. Based on the records and information you provided, you did not demonstrate that you adequately tested your finished drug products prior to release and distribution. For example, the test reports that you provided in your response do not demonstrate that you tested for identity and assay testing for your active ingredient (b)(4) . 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.