FDA 483 - Amphastar Nanjing Pharmaceuticals Inc - September 19, 2025

Amphastar Nanjing Pharmaceuticals, Inc. in Nanjing, China, was inspected for drug substance manufacturing and received a Form 483 with seven observations. The inspection revealed significant deficiencies across facility design, quality unit oversight, material management, manufacturing controls, laboratory procedures, documentation, and risk assessment, indicating a broad lack of cGMP compliance. These issues collectively pose a high risk of microbial contamination and product quality impact.