483
Wuxi STA Pharmaceutical Co., LtdWuxi STA Pharmaceutical Co., Ltd – FDA 483, Mar 3, 2023
Record Details
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.
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