# FDA 483 - Zhejiang Hisun Pharmaceutical Co., Ltd. - June 07, 2019

Source: https://www.keypedia.com/records/483/zhejiang-hisun-pharmaceutical-co-ltd/43ac2a52-29ad-4d11-b102-c322a0e8e66b

> FDA 483 for Zhejiang Hisun Pharmaceutical Co., Ltd. on June 07, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Hisun Pharmaceutical Co., Ltd.
- Inspection Date: 2019-06-07
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Zhejiang Hisun Pharmaceutical Co., Ltd. in Taizhou, Zhejiang, China, was inspected from June 3-7, 2019, revealing significant deficiencies in equipment maintenance, environmental monitoring, cleaning validation, and raw material storage. The inspection found corroded and dirty manufacturing equipment, an inadequate environmental monitoring SOP, a lack of microbiological testing in cleaning validation, and insect infestation in a raw material warehouse. These issues indicate a moderate level of severity concerning manufacturing controls and facility sanitation.

## Related Documents

- [WARNING_LETTER - 2015-03-07](https://www.keypedia.com/records/warning_letter/zhejiang-hisun-pharmaceutical-co-ltd/1c80aaa0-7c21-48ef-8a73-80a5561a3e9f)
- [483 - 2017-01-19](https://www.keypedia.com/records/483/zhejiang-hisun-pharmaceutical-co-ltd/5bce805f-5cef-44fe-bc93-6f7b46060574)
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- [483 - 2017-08-07](https://www.keypedia.com/records/483/zhejiang-hisun-pharmaceutical-co-ltd/782a5325-2b6a-4fd5-a558-9bd88056c204)
- [483 - 2017-08-11](https://www.keypedia.com/records/483/zhejiang-hisun-pharmaceutical-co-ltd/79173a11-bcaa-4b81-8e6b-2662fd1b9d1a)

## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.keypedia.com/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)

Company: https://www.keypedia.com/companies/zhejiang-hisun-pharmaceutical-co-ltd/38a26f64-d8df-4781-8322-3606f62da25d

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