FDA 483 - Fuji Yakuhin Co., Ltd. - November 26, 2019

An FDA inspection of Fuji Yakuhin Co., Ltd. in Toyama-shi, Japan, a manufacturer of sterile drug products, revealed significant deficiencies. Observations included inadequate aseptic process validation, insufficient disinfectant efficacy studies, and critical issues with electronic record integrity and retention. Additionally, the firm failed to adequately qualify suppliers for container and closure components.