FDA 483 - Otsuka Pharmaceutical Co., Ltd. - June 17, 2025

An FDA inspection of Otsuka Pharmaceutical Co., Ltd. in Naka-Gun, Tokushima, Japan, a sterile drug product manufacturer, revealed significant deficiencies. The firm failed to establish adequate written procedures for production and process controls, particularly concerning aseptic processing validation and environmental monitoring. Additionally, laboratory controls for growth promotion testing were found to be deficient.