FDA 483 - Asahi Kasei Finechem Co., Ltd. - November 14, 2025

An FDA inspection of Asahi Kasei Finechem Co., Ltd. in Nobeoka, Japan, an API manufacturer, revealed a significant quality control issue. The firm failed to perform method validation studies on in-house developed test methods and method verification studies on USP methods used for finished product release testing. This deficiency compromises the firm's ability to ensure product quality and compliance with specifications.