FDA WARNING_LETTER - Fuller Industries Inc. - February 17, 2023

On June 28, 2023, the FDA issued a Warning Letter to Fuller Industries Inc. following an inspection from February 15-17, 2023, at their Great Bend, KS drug manufacturing facility (FEI 1922337). The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products, including OTC topical antibacterial hand soaps and hand sanitizers, adulterated under 21 U.S.C. 351(a)(2)(B).

The firm's March 2, 2023, response to the FDA Form 483 was deemed inadequate. Key violations included: 1. **Failure of the Quality Control Unit (QCU) (21 CFR 211.22):** The QCU did not provide adequate oversight to ensure drug products complied with CGMP and met specifications. This included insufficient oversight of manufacturing, lack of complete batch reviews, inadequate investigation oversight, and deficiencies in stability-indicating methods and studies. 2. **Inadequate Component Testing (21 CFR 211.84(d)(1) and 211.84(d)(2)):** The firm failed to perform adequate identity testing for each component lot, specifically propylene glycol (for DEG/EG) and ethanol (for methanol), relying on supplier COAs without validation.