483
Shanghai Henlius Biologics Co., Ltd.Shanghai Henlius Biologics Co., Ltd. – FDA 483, Mar 11, 2025
Record Details
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.
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ID · d6806e72-e2ac-48ef-93a4-336d3aff995b
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