# FDA 483 - Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site) - July 03, 2026

Source: https://www.keypedia.com/records/483/jiangsu-hengrui-pharmaceuticals-co-ltd-dongjin-road-site/7acbb154-70ee-43e1-bcf9-fb567bc3a667

> FDA 483 for Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site) on July 03, 2026. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Dongjin Road Site)
- Inspection Date: 2026-07-03
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Jiangsu Hengrui Pharmaceuticals Co., Ltd. in Lianyungang, China, was inspected by the FDA from 06/23/2026 to 07/03/2026. The inspection revealed significant deficiencies in aseptic processing, quality control, environmental monitoring, laboratory controls, and equipment identification, indicating a lack of adequate controls to ensure the sterility and quality of drug products. These issues raise serious concerns about the firm's compliance with cGMP regulations for sterile injectable manufacturing.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/jiangsu-hengrui-pharmaceuticals-co-ltd-dongjin-road-site/6a83eb5d-8c88-4934-b86a-ab09a2182318)

## Related Officers

- [Investigator](https://www.keypedia.com/people/marvin-d-jones/3101a8da-f5c1-4e0c-b4b1-b09be181be36)
- [Eileen A. Liu](https://www.keypedia.com/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

Company: https://www.keypedia.com/companies/jiangsu-hengrui-pharmaceuticals-co-ltd-dongjin-road-site/91cc5f1a-20dc-4832-bbdf-0af7d9268c3b

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3