483
Huzhou Arthur Pharmaceutical Co., Ltd.Huzhou Arthur Pharmaceutical Co., Ltd. – FDA 483, Sep 23, 2025
Record Details
An FDA inspection of Huzhou Arthur Pharmaceutical Co., Ltd. in Huzhou, China, a manufacturer of sterile drugs, revealed significant deficiencies in their aseptic processing. Observations included inadequate validation of aseptic processes, ineffective cleaning and disinfection systems for aseptic areas, and shortcomings in environmental monitoring practices. These issues raise concerns about the prevention of microbiological contamination in sterile drug products.
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ID · c76e130a-39d0-4158-a268-c650f81904f2
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