# FDA 483 - Beigene (Suzhou) Co., Ltd. - June 16, 2023

Source: https://www.keypedia.com/records/483/beigene-suzhou-co-ltd/ea0358d7-576e-42a1-9d4e-45def2af5b8e

> FDA 483 for Beigene (Suzhou) Co., Ltd. on June 16, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Beigene (Suzhou) Co., Ltd.
- Inspection Date: 2023-06-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of BeiGene (Suzhou) Co., Ltd, a drug manufacturer, revealed significant deficiencies in laboratory controls, analytical method validation, data integrity practices, and equipment qualification. The firm failed to ensure scientifically sound test procedures, adequately validate an HPLC method, maintain data integrity for testing systems, and properly qualify a particle size meter. These issues indicate a lack of assurance in the quality and purity of their drug products.

## Related Officers

- [Jingjing Zhao, Ph.D.](https://www.keypedia.com/people/jingjing-zhao-phd/28f52c94-6f09-454c-b74f-62d6e2e9c85c)
- [investigator](https://www.keypedia.com/people/john-j-bernal/315c4532-4004-43f9-86e1-1bde15e9b2a6)
- [Lead  Biologist](https://www.keypedia.com/people/leiyun-w-boone/454ce531-ae82-4ae4-9b3d-8e4e8afed127)
- [Yiwei Li](https://www.keypedia.com/people/yiwei-li/e5ea2c24-8e1e-43be-be23-e276b8848cff)

Company: https://www.keypedia.com/companies/beigene-suzhou-co-ltd/10b8c1b1-d4b8-4272-a5bd-d1615d0df568

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