# FDA 483 - Wuxi Biologics Co Ltd - April 16, 2019

Source: https://www.keypedia.com/records/483/wuxi-biologics-co-ltd/ce1e9abe-795e-4422-8c9f-c280cc83102e

> FDA 483 for Wuxi Biologics Co Ltd on April 16, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wuxi Biologics Co Ltd
- Inspection Date: 2019-04-16
- Product Type: biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: Wuxi Biologics Co Ltd, a biotech API and sterile finished dose manufacturer in Wuxi, Jiangsu, P.R.C., was cited for four observations during an FDA inspection. The inspection revealed deficiencies in quality control unit procedures for material supplier management, failure to address critical quality attribute trends, insufficient reserve sample retention, and inadequate analytical method evaluation. These issues indicate a lack of robust quality systems and control over manufacturing processes.

## 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 - 2021-04-02](https://www.keypedia.com/records/483/wuxi-biologics-co-ltd/111c7c36-f8e2-431d-b801-d519aea1a4b2)
- [483 - 2023-05-09](https://www.keypedia.com/records/483/wuxi-biologics-co-ltd/259807ac-8822-440f-8082-73414567e212)

## Related Officers

- [Ramesh Potla](https://www.keypedia.com/people/ramesh-potla/0df722fa-b514-49ac-8fcd-58363e086d32)
- [Senior Director Technical](https://www.keypedia.com/people/christopher-t-middendorf/0fea23f5-ffe6-49a0-ac33-780317707c71)
- [Mekonnen Lemma Dechassa](https://www.keypedia.com/people/mekonnen-lemma-dechassa/a210168b-86f6-4e9b-9f66-c1244abff0f9)

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

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