# FDA 483 - Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site) - January 16, 2024

Source: https://www.globalkeysolutions.net/records/483/jiangsu-hengrui-pharmaceuticals-co-ltd-huanghe-road-site/f1c77da3-4ebf-4928-83f6-164ebfa4bbe0

> FDA 483 for Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site) on January 16, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site)
- Inspection Date: 2024-01-16
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Jiangsu Hengrui Pharmaceuticals Co., Ltd (Huanghe Road Site) received an FDA Form 483 with eight observations during an inspection from January 8-16, 2024. The inspection revealed significant deficiencies in aseptic processing validation, cleaning validation, container closure integrity testing, and quality unit oversight. Furthermore, issues included inadequate data integrity, lack of control over computerized systems, poor facility maintenance, and obstruction during the inspection.

## Related Documents

- [483 - 2024-01-16](https://www.globalkeysolutions.net/records/483/jiangsu-hengrui-pharmaceuticals-co-ltd-huanghe-road-site/9c7f1a0b-501b-4a40-b8eb-2b6869ca0071)

## Related Officers

- [Qiao Y. Bobo](https://www.globalkeysolutions.net/people/qiao-y-bobo/c57c1128-9181-4c2a-81f9-cb9a171ece38)
- [Arsen Karapetyan](https://www.globalkeysolutions.net/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

Company: https://www.globalkeysolutions.net/companies/jiangsu-hengrui-pharmaceuticals-co-ltd-huanghe-road-site/02eeb237-fdd8-40a0-b45c-d4d88f49eb6c

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