FDA 483 - Shanghai Henlius Biologics Co., Ltd. - March 11, 2025

An FDA inspection of Shanghai Henlius Biologics Co., Ltd. in Songjiang District, Shanghai, China, revealed inadequate quality unit oversight. Specifically, the firm's visual inspection process for drug product samples was found to be inadequate, and deficiencies were noted in the qualification and requalification studies of HEPA filters for the ABS filling line. These observations highlight concerns with the firm's quality control and environmental monitoring practices.