# FDA 483 - Zhejiang Chinese Medical University - November 13, 2024

Source: https://www.globalkeysolutions.net/records/483/zhejiang-chinese-medical-university/617b0705-cb78-4888-a98c-02c74f80dc4d

> FDA 483 for Zhejiang Chinese Medical University on November 13, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Chinese Medical University
- Inspection Date: 2024-11-13
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Zhejiang Chinese Medical University, a contract testing laboratory in Hangzhou, China, revealed significant deficiencies in its quality control unit and computer system controls. The quality control unit failed to oversee critical records and approve procedures, while the computerized pyrogen testing system lacked appropriate controls, allowing the Technical Manager to delete samples and test records. These issues indicate a lack of robust quality management and potential data integrity risks.

## Related Officers

- [Jose M. Cayuela](https://www.globalkeysolutions.net/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)

Company: https://www.globalkeysolutions.net/companies/zhejiang-chinese-medical-university/299d7779-2654-4da9-a5c1-249f52d9fe49

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8