# FDA 483 - Zhejiang Hisun Pharmaceutical Co., Ltd. - August 07, 2017

Source: https://www.globalkeysolutions.net/records/483/zhejiang-hisun-pharmaceutical-co-ltd/782a5325-2b6a-4fd5-a558-9bd88056c204

> FDA 483 for Zhejiang Hisun Pharmaceutical Co., Ltd. on August 07, 2017. 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: 2017-08-07
- Product Type: drugs
- Office Name: Division of International Drug Quality
- Summary: Zhejiang Hisun Pharmaceutical Co., Ltd., an API/Finished Drug Product Manufacturer in Taizhou, China, was cited for multiple significant deficiencies during an FDA inspection. The firm failed to ensure data integrity in laboratory records, maintain adequate equipment cleaning procedures, and appropriately monitor storage conditions. Additionally, issues included a lack of contemporaneous record-keeping, insufficient documentation for manufacturing process changes and microbial limit testing, incomplete process validation studies, and poor facility maintenance in API storage areas.

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## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/parul-m-patel/2a7e7ff1-6b9b-42d7-8bc4-03eeecc5cecc)
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Company: https://www.globalkeysolutions.net/companies/zhejiang-hisun-pharmaceutical-co-ltd/38a26f64-d8df-4781-8322-3606f62da25d

Office: https://www.globalkeysolutions.net/offices/division-of-international-drug-quality/f787ba47-67be-40ca-b4c5-4b664b9c1591