FDA warning Letter issued 02.04.2024

Synopsis Identity testing of incoming components: The firm did not conduct adequate testing to verify the identity of each component of its drug products, including active ingredient ethanol for methanol contamination. Finished drug product testing: There was a lack of appropriate laboratory determination of satisfactory conformance to final specifications for drug products before release, including identity and strength of the active ingredients. Stability program: The firm failed to establish and follow an adequate written testing program to assess the stability characteristics for the OTC hand sanitizer drug products. Quality Unit (QU): The QU did not effectively oversee the quality of drug manufacturing operations. 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. Your QU is responsible for fully exercising its authority and responsibilities. FDA is concerned that your QU may not be conducting appropriate oversight regarding CGMP operations. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download