FDA 483 - FUJIFILM Wako Chemicals U.S.A. Corporation - May 10, 2024

An FDA inspection of FUJIFILM Wako Chemicals U.S.A. Corporation in Richmond, VA, revealed significant deficiencies in their manufacturing processes for IVD products. Observations included inadequate control and monitoring of production, failures in equipment calibration and maintenance, and issues with device history record documentation. These findings indicate a lack of adherence to established quality system procedures.