FDA 483 - Zhejiang Hisoar Chuannan Pharmaceutical Co. Ltd. - September 20, 2019

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.