FDA 483 - GOJO Industries Inc - April 09, 2026

An FDA inspection of GOJO Industries LLC in Cuyahoga Falls, OH, revealed significant deficiencies in laboratory controls, drug product storage, and equipment cleaning. The firm failed to establish adequate sampling plans for in-process materials and bulk drug products, did not properly evaluate returned drug products, and had inadequate cleaning procedures for dispensing rooms, posing risks of contamination and compromised product quality. These issues indicate a lack of robust quality assurance practices.