FDA 483 - Fuller Industries, Inc - March 26, 2025

Fuller Industries, Inc., an OTC manufacturer in Great Bend, KS, was cited for significant deficiencies across its manufacturing and quality control operations. The inspection revealed issues with equipment cleaning, component testing, laboratory controls, stability testing, and a complete absence of a functional quality control unit. These findings indicate a systemic lack of adherence to good manufacturing practices, with several repeat observations from a previous inspection.