# FDA 483 - Hisun Pharmaceutical Hangzhou Co., Ltd - Unknown Date

Source: https://www.keypedia.com/records/483/hisun-pharmaceutical-hangzhou-co-ltd/5464f3ae-a640-4ce5-8975-cbc0a66e133b

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

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## Details

- Record Type: 483
- Company Name: Hisun Pharmaceutical Hangzhou Co., Ltd
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Hisun Pharmaceutical Hangzhou Co. Ltd. in Fuyang District, Hangzhou, China, was inspected regarding its API and sterile finished dosage drug manufacturing. The inspection revealed significant data integrity issues, including falsified environmental and water monitoring records, and widespread failures in aseptic processing controls. Additionally, the firm demonstrated inadequate quality management oversight, insufficient cleaning procedures, and a lack of thorough investigations.

## Related Documents

- [483 - 2021-07-20](https://www.keypedia.com/records/483/hisun-pharmaceutical-hangzhou-co-ltd/886a3c8f-3427-4583-a592-d0eb37e7ed02)

## Related Officers

- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)
- [Sandra A. Hughes](https://www.keypedia.com/people/sandra-a-hughes/ee1b9542-fe28-4618-a666-67a1ff736481)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd