# FDA 483 - Zhejiang Tianyu Pharmaceutical Co. Ltd. - November 21, 2024

Source: https://www.keypedia.com/records/483/zhejiang-tianyu-pharmaceutical-co-ltd/1a60a15b-bf58-4a25-b4f2-51d949d8d3f9

> FDA 483 for Zhejiang Tianyu Pharmaceutical Co. Ltd. on November 21, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zhejiang Tianyu Pharmaceutical Co. Ltd.
- Inspection Date: 2024-11-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Zhejiang Tianyu Pharmaceutical Co., Ltd. in Huangyan, China, an API manufacturer, revealed significant deficiencies in quality control and equipment cleaning. The firm failed to establish proper impurity profiles for identified and unidentified impurities in recovered materials and intermediates, and also lacked appropriate cleaning schedules for storage tanks, leading to potential contamination risks. These issues indicate a lack of robust quality systems for API manufacturing.

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## Related Officers

- [Pratik S. Upadhyay](https://www.keypedia.com/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)
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Company: https://www.keypedia.com/companies/zhejiang-tianyu-pharmaceutical-co-ltd/b7ecf3cd-082c-48b5-94e1-8adeba7ce167

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