483
Zhejiang Huahai PharmaceuticalZhejiang Huahai Pharmaceutical – FDA 483, Aug 3, 2018
Record Details
An FDA inspection of Zhejiang Huahai Pharmaceutical Co., Ltd. revealed significant deficiencies across its quality, production, and laboratory systems. The firm demonstrated inadequate change control, insufficient process and cleaning validation, and poor deviation investigation practices. These issues indicate a systemic failure to ensure the quality and purity of Active Pharmaceutical Ingredients (APIs) manufactured at the facility.
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ID · 52b9509e-bd30-4536-a4de-b2064ff256b1
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