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

Source: https://www.globalkeysolutions.net/records/483/zhejiang-hisoar-chuannan-pharmaceutical-co-ltd/821da991-13b4-4894-ada1-9ef1ab13f09a

> FDA 483 for Zhejiang Hisoar Chuannan Pharmaceutical Co. Ltd. on September 20, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Hisoar Chuannan Pharmaceutical Co. Ltd.
- Inspection Date: 2019-09-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Officers

- [Sena G. Dissmeyer](https://www.globalkeysolutions.net/people/sena-g-dissmeyer/4dbb1255-95e4-402b-8bb3-75c4f7940c13)

Company: https://www.globalkeysolutions.net/companies/zhejiang-hisoar-chuannan-pharmaceutical-co-ltd/49f209c0-5102-42ad-b7ce-27529f15c6a5

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1