FDA 483 - Nippon Protein Co., Ltd. Ashikaga Plant - June 27, 2025

Nippon Protein Co., Ltd. Ashikaga Plant, an API manufacturer in Japan, received a Form 483 with three observations during an FDA inspection from June 23-27, 2025. The observations primarily concern failures in quality control systems, including inadequate investigations into discrepancies, lack of cleaning validation, and insufficient equipment qualification processes. These issues indicate a moderate level of concern regarding the firm's adherence to good manufacturing practices.