FDA 483 - Jiangsu Hengrui Pharmaceuticals Co., Ltd. - April 04, 2025

An FDA inspection of Jiangsu Hengrui Pharmaceuticals Co., Ltd. in Lianyungang, China, revealed a significant quality system deficiency. The firm failed to establish adequate written procedures for annual evaluations and its annual product review was insufficient in trending to decrease visible particulates in sterile injection products released to the United States.