1Laboratory and QC controls
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 failed to adequately test finished batches of your medical gases for impurities and for the identity and strength of your active ingredients, Oxygen, USP and Nitrogen, NF. Full release testing, which…
2Quality unit oversight
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 and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated (21 CFR 211.22(a)). Your firm failed to establish an adequate QU with the…
3Equipment and facility
Your firm failed to routinely calibrate, inspect, or check according to a written program designed to assure proper performance of and to maintain adequate written records of calibration checks and inspections of automatic, mechanical, electronic equipment, or other types of equipment, including computers, used in the manufacture, processing, packing, and holding of a drug product (21 CFR 211.68(a)). You failed to routinely calibrate numerous pieces of equipment that your…
4Deviation, CAPA, and investigation
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). Your firm failed to adequately investigate manufacturing and testing discrepancies during the production of your medical gases. For example, our investigator observed recurrent container-closure defects, such as neck leaks and valves, identified during…
5Material and supplier control
Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)). Your firm failed to conduct identity testing for each component lot used in medical gas manufacturing, including Oxygen, USP and Nitrogen, NF. Additionally, you relied on the certificates of analysis…
