FDA 483 - WuXi ATU Co., Ltd. - March 12, 2025

WUXI ATU Co., Ltd., a gene therapy manufacturer in Wuxi, China, received 13 observations during an FDA inspection from March 3-12, 2025. The inspection revealed significant deficiencies across aseptic processing, laboratory investigations, batch record completion, facility and equipment maintenance, documentation practices, and quality oversight of electronic data and CAPA systems. These issues indicate a broad lack of control over critical manufacturing and quality processes, posing potential risks to product quality and patient safety.