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

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.