Findings citing 21 CFR 211.194

Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)). Your laboratory records did not include complete data to support the analyses performed. For example, your analytical notebooks documented approximately (b)(4) microbiology plates for finished drug products and approximately (b)(4) media plates for testing (b)(4) samples as…

Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)). Your laboratory records lacked complete and original data to support the analyses performed. For example: A. During the inspection, we requested the testing worksheets from the (b)(4) studies you conducted on a compounding tank and its transfer line, which included endotoxin and…

Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)). You failed to accurately document microbiology sampling and testing results for components used in your over-the-counter (OTC) drug products. Your laboratory records did not accurately reflect activities performed. For example, your microbiologist documented the collection of routine…

Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and (d). 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. Specifically, your QU failed to: Ensure adequate control over laboratory data including…

Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)). Your laboratory records lacked complete and original data to support the analyses performed. For example, our investigator asked for raw data for microbiological release and stability testing of your over-the-counter (OTC) drug products prior to May 2025 and your firm’s…

Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures (21 CFR 211.22(d)). You manufacture over-the-counter (OTC) oral liquid drug products including, but not limited to, analgesics and cough and cold products marketed for infants and children. You failed to ensure adequate quality unit (QU) oversight for release of your OTC drug products. For example, your QU failed to…