# FDA EIR - Wuxi Biologics Co Ltd - April 02, 2021

Source: https://www.keypedia.com/records/eir/wuxi-biologics-co-ltd/49fcfc39-0021-4cc2-8bce-513930c8167e

> FDA EIR for Wuxi Biologics Co Ltd on April 02, 2021. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Wuxi Biologics Co Ltd
- Inspection Date: 2021-04-02
- Product Type: Biologics
- Summary: An FDA surveillance inspection of Wuxi Biologics Co Ltd, a biological therapeutic drug substance and drug product manufacturer located in Wuxi, China, was conducted from March 22 to April 2, 2021. This inspection, carried out under current Good Manufacturing Practices (cGMP) regulatory frameworks for pre-approval and sterile drug processes, examined critical systems including Quality, Production, Materials, Facilities and Equipment, and Laboratory operations. The overall inspection conclusion was classified as "Voluntary Action Indicated" (VAI).

The inspection identified six significant observations detailed in an FDA 483 form. Key issues included inadequate controls over computer systems to prevent data changes, deficient Quality Unit oversight in controlled document issuance, and a lack of adequate preventative maintenance schedules for equipment. Additionally, the FDA cited deficiencies in component specifications, inconsistent initiation of effectiveness checks for corrective and preventative actions (CAPA) after deviation investigations, and a failure to thoroughly review unexplained discrepancies or out-of-specification results. Management at Wuxi Biologics acknowledged these observations and committed to implementing the necessary corrections, confirming their plan to submit a comprehensive written response to the FDA.

## Related Documents

- [483 - 2019-04-16](https://www.keypedia.com/records/483/wuxi-biologics-co-ltd/1e3cf4c9-91d3-4f51-9777-fa2ca89cedb2)
- [EIR - 2019-04-08](https://www.keypedia.com/records/eir/wuxi-biologics-co-ltd/526d92cf-0cca-4b1c-870b-888c1217bf8f)
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- [483 - 2019-04-16](https://www.keypedia.com/records/483/wuxi-biologics-co-ltd/ce1e9abe-795e-4422-8c9f-c280cc83102e)
- [483 - 2023-05-09](https://www.keypedia.com/records/483/wuxi-biologics-co-ltd/259807ac-8822-440f-8082-73414567e212)

## Related Officers

- [Branch Chief, Foreign Pharmaceutical Quality Inspection at FDA](https://www.keypedia.com/people/kevin-a-gonzalez/3f0a5230-3804-4df2-9a5e-3ea805ba9b79)
- [investigator](https://www.keypedia.com/people/jonathan-w-chapman/5b5134c3-71f9-4212-9429-4554d91e8aa9)
- [recipient](https://www.keypedia.com/people/xuejian-xu/9d127323-6fef-4695-81d6-3a01e314a00d)
- [other](https://www.keypedia.com/people/marisol-lendor/fba81bee-aacb-44ff-add9-6e6c8acdd106)

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