483
Zhejiang Hisoar Chuannan Pharmaceutical Co. Ltd.Zhejiang Hisoar Chuannan Pharmaceutical Co. Ltd. – FDA 483, Sep 20, 2019
Record Details
An FDA inspection of Zhejiang Hisun Chuannan Pharmaceutical Co., Ltd. in Linhai Zone, China, revealed significant deficiencies in quality control and manufacturing processes. The firm failed to thoroughly investigate out-of-specification results and implement effective corrective actions. Additionally, the company did not adequately validate critical process parameters for product manufacturing.
- Inspection date
- September 20, 2019
- Product type
- drugs
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ID · 821da991-13b4-4894-ada1-9ef1ab13f09a
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