# FDA 483 - Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site) - July 16, 2026

Source: https://www.keypedia.com/records/483/jiangsu-hengrui-pharmaceuticals-co-ltd-huanghe-road-site/dcfc67cd-7925-46e3-aa1d-6a3ada69852e

> FDA 483 for Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site) on July 16, 2026. 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: 2026-07-16
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Jiangsu Hengrui Pharmaceuticals Co., Ltd. received a Form FDA 483 with three observations related to manufacturing sterile drug products. The firm failed to establish adequate procedures for preventing microbiological contamination and validating sterilization processes, particularly concerning airflow visualization studies. Additionally, the quality control unit lacked proper oversight, resulting in missing records and significant errors in batch production records, and master production records were deficient in manufacturing instructions and specifications.

## Related Documents

- [483 - 2024-01-16](https://www.keypedia.com/records/483/jiangsu-hengrui-pharmaceuticals-co-ltd-huanghe-road-site/f1c77da3-4ebf-4928-83f6-164ebfa4bbe0)
- [483 - 2024-01-16](https://www.keypedia.com/records/483/jiangsu-hengrui-pharmaceuticals-co-ltd-huanghe-road-site/9c7f1a0b-501b-4a40-b8eb-2b6869ca0071)

## 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-huanghe-road-site/02eeb237-fdd8-40a0-b45c-d4d88f49eb6c

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