# FDA 483 - Jiangsu Hengrui Pharmaceuticals Co., Ltd. - April 04, 2025

Source: https://www.keypedia.com/records/483/jiangsu-hengrui-pharmaceuticals-co-ltd/eb46bf2d-a78b-4bac-87f4-f509775ee966

> FDA 483 for Jiangsu Hengrui Pharmaceuticals Co., Ltd. on April 04, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Jiangsu Hengrui Pharmaceuticals Co., Ltd.
- Inspection Date: 2025-04-04
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Jiangsu Hengrui Pharmaceuticals Co., Ltd. in Lianyungang, China, revealed a significant quality system deficiency. The firm failed to establish adequate written procedures for annual evaluations and its annual product review was insufficient in trending to decrease visible particulates in sterile injection products released to the United States.

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## Related Officers

- [Sara H. Gabel](https://www.keypedia.com/people/sara-h-gabel/cd0cd510-ef95-4322-a766-503c994c1f64)

Company: https://www.keypedia.com/companies/jiangsu-hengrui-pharmaceuticals-co-ltd/d8430568-25ba-4cb0-a549-75fa7caf0a45

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8