Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistFuller Industries Inc., a manufacturer of OTC topical drug products including antibacterial hand soaps and hand sanitizers, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The FDA inspection in February 2023 found that the company's quality control unit failed to ensure adequate oversight of drug manufacturing, specifically failing to perform, document, and review assay testing for the active ingredient chloroxylenol (PCMX) in every batch prior to release and distribution, and failing to establish appropriate procedures for investigating out-of-specification results and non-conformances. The company's March 2023 response to the FDA's inspection findings was deemed inadequate because it did not provide sufficient detail or evidence of corrective actions necessary to achieve CGMP compliance.