# FDA 483 - Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API). - August 23, 2019

Source: https://www.keypedia.com/records/483/zhejiang-xianju-pharmaceutical-co-ltd-yangfu-api/6f57f486-b578-4d59-93df-ebd528be8ab2

> FDA 483 for Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API). on August 23, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Xianju Pharmaceutical Co., Ltd. (Yangfu API).
- Inspection Date: 2019-08-23
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Zhejiang Xianju Pharmaceutical Co., Ltd in Xianju, China, revealed one observation concerning the lack of audit trail review for critical analytical instruments. These instruments are used for release testing of APIs destined for the U.S. market, indicating a potential issue with data integrity and quality control practices.

## Related Officers

- [Joel D. Hustedt](https://www.keypedia.com/people/joel-d-hustedt/29440042-08dd-4dce-be48-b55f8e1d7080)

Company: https://www.keypedia.com/companies/zhejiang-xianju-pharmaceutical-co-ltd-yangfu-api/df5b51df-0490-4610-b336-1e15ff50a010

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