Fuller Industries, Inc – FDA 483, Jul 23, 2026

Fuller Industries Inc, an OTC drug manufacturer in Great Bend, KS, was cited for significant deficiencies across multiple areas during an FDA inspection. The observations, many of which are repeats, highlight severe issues with equipment cleaning validation, component testing, laboratory controls including data integrity and environmental conditions, stability testing, and discrepancy investigations. These findings indicate a systemic lack of adherence to cGMP requirements, posing risks to product quality and patient safety.