FDA 483 - Gojo Industries - August 05, 2022

An FDA inspection of Gojo Industries in Wooster, OH, revealed significant deficiencies in laboratory controls and documentation related to their USP Purified Water System. The firm failed to use scientifically sound methods for identifying organisms in the water system and lacked proper documentation for sampling plans and identification guides. Additionally, microbiological testing results were not adequately reviewed and verified by a second person.