# FDA 483 - Hisun Pharmaceutical Hangzhou Co., Ltd - July 20, 2021

Source: https://www.globalkeysolutions.net/records/483/hisun-pharmaceutical-hangzhou-co-ltd/886a3c8f-3427-4583-a592-d0eb37e7ed02

> FDA 483 for Hisun Pharmaceutical Hangzhou Co., Ltd on July 20, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hisun Pharmaceutical Hangzhou Co., Ltd
- Inspection Date: 2021-07-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Hisun Pharmaceutical Hangzhou Co., Ltd, an API and sterile finished dose drug manufacturer, revealed significant deficiencies in pyrogen control, aseptic processing, and facility sanitation. The firm failed to validate cleaning methods, monitor critical process parameters, and maintain clean conditions, leading to potential microbial contamination, particle generation, and adverse drug events in patients. These issues indicate a serious lack of control over manufacturing processes and facility maintenance.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/hisun-pharmaceutical-hangzhou-co-ltd/5464f3ae-a640-4ce5-8975-cbc0a66e133b)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)

Company: https://www.globalkeysolutions.net/companies/hisun-pharmaceutical-hangzhou-co-ltd/08054db1-b8fe-4c18-8ee5-e6098cb2e427

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