FDA 483 - Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Jinqiao Road Site) - April 15, 2026

Jiangsu Hengrui Pharmaceuticals in Lianyungang, China, received a Form 483 citing significant deficiencies in its sterile drug product and API manufacturing operations. The inspection revealed widespread issues including inadequate validation of sterilization processes, deficiencies in aseptic technique and environmental monitoring, and insufficient quality control oversight. These findings indicate a high risk of microbiological contamination and compromised product quality for sterile products.