FDA 483 - GE Healthcare Shanghai Co., Ltd. - October 30, 2025

An FDA inspection of GE Healthcare Shanghai Co. Ltd., a sterile drug manufacturer in Shanghai, China, revealed significant deficiencies across multiple areas. Observations included failures in retesting drug product container closures after contamination, inadequate cleaning and maintenance of equipment, and insufficient controls over computer systems for manufacturing data backup. These issues indicate a lack of robust quality control and data integrity practices.