FDA 483 - Akeso Biopharma Co., Ltd. - March 04, 2025

Akeso Biopharma, Co., Ltd. in Zhongshan, China, was cited for significant deficiencies during an FDA inspection of its drug substance and drug product manufacturing. The firm's visual inspection program, laboratory controls, and quality unit oversight were found to be inadequate. Additionally, issues were identified with procedures for preventing microbiological contamination, the design and maintenance of facilities and equipment, and non-conformance to submitted information regarding reference standard testing.