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

Source: https://www.keypedia.com/records/483/wuxi-sta-pharmaceutical-co-ltd/ada6e1b2-a1f6-4eff-b151-0d16cc88a7a8

> FDA 483 for Wuxi STA Pharmaceutical Co., Ltd on March 03, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wuxi STA Pharmaceutical Co., Ltd
- Inspection Date: 2023-03-03
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Documents

- [483 - 2023-03-03](https://www.keypedia.com/records/483/wuxi-sta-pharmaceutical-co-ltd/0cb46d3e-9f9a-4561-ae15-b80b7e6556da)

## Related Officers

- [Tonia F. Bernard](https://www.keypedia.com/people/tonia-f-bernard/607c8dae-63cb-491a-8d7d-ddfa0ee1b67d)

Company: https://www.keypedia.com/companies/wuxi-sta-pharmaceutical-co-ltd/892c7730-c0f9-4b49-9c80-f65ee1e21b57

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1