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Talk to a SpecialistTalk to a SpecialistNational Chemical Laboratories, a pharmaceutical manufacturer of OTC topical drugs including benzalkonium chloride-based hand sanitizers, violated Current Good Manufacturing Practice (CGMP) regulations during an FDA inspection in May 2023. The company failed to validate and establish the reliability of component suppliers' test analyses at appropriate intervals, relying instead on supplier certificates of analysis without conducting independent testing to verify that benzalkonium chloride and other components conformed to specifications. This failure to adequately test components meant the firm lacked scientific evidence that materials were suitable for use in drug manufacturing, rendering their finished products adulterated. The company's corrective action plan to establish a supplier qualification program and conduct retrospective testing of affected lots was deemed inadequate by the FDA.