# FDA 483 - Wuxi Biologics Co Ltd - April 02, 2021

Source: https://www.keypedia.com/records/483/wuxi-biologics-co-ltd/111c7c36-f8e2-431d-b801-d519aea1a4b2

> FDA 483 for Wuxi Biologics Co Ltd on April 02, 2021. Product: N/A. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wuxi Biologics Co Ltd
- Inspection Date: 2021-04-02
- Office Name: Office of Pharmaceutical Quality Operations
- Summary: This FDA Form 483 details multiple observations from an inspection.

**Computer System Controls:** The facility lacks adequate controls over computer systems. Procedure WX-SOP-00154 for the Process Automation System (b)(4) Batch (b)(4) requires QA approval for parameter modifications but not verification of accuracy post-change. Second-person verification is required but not always performed, as evidenced by missing signatures for an alarm limit change on 02/08/2021. This led to Deviation DV39507 for (b)(4) Lot (b)(4), requiring reprocessing.

**Quality Unit Oversight:** The Quality Assurance department has deficient oversight of controlled document issuance. There are inadequate controls for the distribution and reconciliation of quality forms. For example, Form WX-FORM-000970-09 (Registration Form for Samples for Analyses) lacks an adequate reconciliation plan, and Form WX-FORM-002218-02 (Incoming Material Checklist) is issued by the Warehouse Documentation group without QA oversight.

**Preventative Maintenance:** Adequate preventative maintenance schedules are not established for equipment, specifically (b)(4) (MFG-UOE-3290), (b)(4) (MFG-DFC-3016), and (b)(4) (MFG-DFC-3017). WX-SOP-0

## 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)
- [EIR - 2019-04-08](https://www.keypedia.com/records/eir/wuxi-biologics-co-ltd/526d92cf-0cca-4b1c-870b-888c1217bf8f)
- [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

- [investigator](https://www.keypedia.com/people/jonathan-w-chapman/5b5134c3-71f9-4212-9429-4554d91e8aa9)

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

Office: https://www.keypedia.com/offices/office-of-pharmaceutical-quality-operations/6b0153a9-c1d1-46a5-8b10-836d2ae44ffe