FDA 483 - Fuller Industries, Inc - February 17, 2023

Fuller Industries, Inc., an OTC manufacturer in Great Bend, KS, was cited for significant deficiencies in laboratory controls, quality systems, and record-keeping during an FDA inspection. Observations included unvalidated test methods, uncontrolled procedures, and a failure to investigate out-of-specification results for antibacterial hand soap, which was subsequently released for distribution. The firm also lacked proper written procedures for product evaluations, supplier qualification, and document approval, indicating a systemic breakdown in quality assurance.