FDA 483 - Wuxi STA Pharmaceutical Co., Ltd - March 03, 2023

An FDA inspection of WuXi STA Pharmaceutical Co., LTD. in WuXi, China, revealed a significant quality control issue. The firm failed to perform routine calibrations of mechanical measuring instruments, including balances and sensors, according to its own written procedures and calibration plan. This lapse affects instruments used in the manufacturing process, indicating a potential risk to product quality.