FDA 483 - Pharmaron Shaoxing Co., Ltd. - June 04, 2025

An FDA inspection of Pharmaron Shaoxing Co., Ltd. in Shaoxing, China, revealed significant deficiencies in their quality control systems for API manufacturing. The firm failed to conduct adequate investigations into out-of-specification results, lacking sufficient evidence for root cause determination. Additionally, the company did not maintain proper backup files for computerized system data and lacked records for the cleaning and maintenance of manufacturing equipment.