483
Shanghai Henlius Biologics Co., Ltd.FDA 483 - Shanghai Henlius Biologics Co., Ltd. - August 01, 2023
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Record Details
Shanghai Henlius Biologics Co., Ltd. was inspected from July 26 to August 4, 2023, and received a Form 483 with four observations. The inspection revealed deficiencies in fill line setup procedures, ambient storage area qualifications, facility microbial control, and documentation for a specific test method. These issues indicate a need for improved quality control and procedural adherence.
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ID · 80493937-1845-4891-b9a3-0375deb27cdd