# FDA 483 - Wuxi Biologics Co Ltd - May 09, 2023

Source: https://www.keypedia.com/records/483/wuxi-biologics-co-ltd/cbe568d3-a88d-4653-bf1e-ac4dd349213d

> FDA 483 for Wuxi Biologics Co Ltd on May 09, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wuxi Biologics Co Ltd
- Inspection Date: 2023-05-09
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Wuxi Biologics Co. Ltd. in Wuxi, Jiangsu, China, a drug substance and sterile drug product manufacturer, was cited for significant deficiencies across its quality unit oversight, visual inspection program, aseptic processing area cleaning, in-process parameter setup, and validation studies. The inspection revealed issues with batch release, sterility testing, contamination control, particle inspection, hold time validations, and cleaning documentation. These observations indicate a systemic lack of control over critical manufacturing processes and quality assurance.

## Related Documents

- [483 - 2019-04-16](https://www.keypedia.com/records/483/wuxi-biologics-co-ltd/1e3cf4c9-91d3-4f51-9777-fa2ca89cedb2)
- [EIR - 2021-04-02](https://www.keypedia.com/records/eir/wuxi-biologics-co-ltd/49fcfc39-0021-4cc2-8bce-513930c8167e)
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- [483 - 2019-04-16](https://www.keypedia.com/records/483/wuxi-biologics-co-ltd/ce1e9abe-795e-4422-8c9f-c280cc83102e)

## Related Officers

- [Jun Liu](https://www.keypedia.com/people/jun-liu/39e5d6f3-32fd-426f-880d-3d840a9faed2)
- [Bo Chi](https://www.keypedia.com/people/bo-chi/9c83477d-58c1-4183-832e-ce8cbd25a521)

Company: https://www.keypedia.com/companies/wuxi-biologics-co-ltd/67a28116-624d-42f6-adae-18cf80094862

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd