# FDA 483 - Hangzhou Huadong Medicine Group Zhejiang Huayi Pharmaceutical Co., LTD. - April 18, 2025

Source: https://www.keypedia.com/records/483/hangzhou-huadong-medicine-group-zhejiang-huayi-pharmaceutical-co-ltd/0fb9e0ec-57f6-4b7c-bf76-e7398d037855

> FDA 483 for Hangzhou Huadong Medicine Group Zhejiang Huayi Pharmaceutical Co., LTD. on April 18, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hangzhou Huadong Medicine Group Zhejiang Huayi Pharmaceutical Co., LTD.
- Inspection Date: 2025-04-18
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Zhejiang Huayi Pharmaceutical Co., Ltd., an API manufacturer in Yiwu, China, was cited for three observations during an FDA inspection. The observations include failures in equipment cleaning, inadequate temperature control for material storage, and the use of unvalidated test procedures for examining microbial culture media plates. These issues indicate a lack of sufficient oversight and control over critical manufacturing and quality processes.

## Related Officers

- [investigator](https://www.keypedia.com/people/timothy-h-vo/08da7ca5-7f58-42bf-8046-e3a1bf879b48)

Company: https://www.keypedia.com/companies/hangzhou-huadong-medicine-group-zhejiang-huayi-pharmaceutical-co-ltd/4fcabfd2-d6e5-41ab-a543-fd9b939f8430

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