# 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/9c7f1a0b-501b-4a40-b8eb-2b6869ca0071

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

---

## Details

- Record Type: 483
- Company Name: Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Huanghe Road Site)
- Inspection Date: 2024-01-16
- Office Name: Office of Pharmaceutical Manufacturing Assessment
- Summary: This FDA Form 483 details multiple observations from an inspection of a facility manufacturing sterile drug products.

**Facility and Operations:** The inspection covered general parenteral workshops, including a filling room with a RABS (Restricted Access Barrier System) and associated Grade A, B, C, and D areas. The facility manufactures products like Injection USP.

**Violations and Observations:**

*   **Aseptic Process Validation Deficiencies:**
    *   Sterilization of product contact equipment (e.g., stopper drums) lacked outer wrapping and cover during transfer, compromising sterility.
    *   Inadequate physical separation between Grade A and Grade B areas, and airflow visualization studies did not cover transitions.
    *   Discrepancies between observed and recorded intervention times during filling (e.g., 3:58 pm - 4:03 pm observed vs. 4:00 pm - 4:01 pm recorded).
    *   Procedure P-01 007 lacked clear definitions for intervention start/stop times.
    *   Process simulation studies (media fills) were not representative of commercial operations, failing to adequately incorporate worst-case interventions (nature, frequency, duration).
    *   Inadequate production operator requalification procedures for interventions; operators performing few or no interventions during media fills were still considered requalified.

*   **Container Closure System Issues:**
    *   Container closure integrity test for

## Related Documents

- [483 - 2024-01-16](https://www.globalkeysolutions.net/records/483/jiangsu-hengrui-pharmaceuticals-co-ltd-huanghe-road-site/f1c77da3-4ebf-4928-83f6-164ebfa4bbe0)

## Related Officers

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

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-pharmaceutical-manufacturing-assessment/fe47b0bd-c1c6-4458-a8c9-15e4b073d3df