FDA 483 - FUJIFILM Wako Chemicals U.S.A. Corporation - September 27, 2018

An FDA inspection of FUJIFILM Wako Chemicals U.S.A. in Richmond, VA, a licensed in-vitro diagnostic device manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate maintenance of device history records, lack of control over non-conforming products, and insufficient validation of quality system software. The findings indicate a need for improved documentation, procedural controls, and environmental monitoring to ensure product quality and regulatory compliance.