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

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