FDA 483 - Shanghai Henlius Biopharmaceuticals Co., Ltd. - May 20, 2026
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The FDA inspection of Shanghai Henlius Biopharmaceutical Co., Ltd. revealed significant deficiencies in manufacturing process control, particularly concerning visible particulates in drug product batches. The firm also demonstrated inadequate investigation practices, retrospective changes to acceptance criteria without proper control, and failures in cleaning validation. Additionally, issues were noted in quality control laboratory procedures, electronic data integrity, equipment control in clean areas, and contamination prevention practices.
ID · 63f556fa-efa4-430b-9800-1c8de5e4400c