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

Jiangsu Hengrui Pharmaceuticals Co., Ltd (Huanghe Road Site) received an FDA Form 483 with eight observations during an inspection from January 8-16, 2024. The inspection revealed significant deficiencies in aseptic processing validation, cleaning validation, container closure integrity testing, and quality unit oversight. Furthermore, issues included inadequate data integrity, lack of control over computerized systems, poor facility maintenance, and obstruction during the inspection.