# FDA 483 - Zhejiang Tianyu Pharmaceutical Co. Ltd. - March 04, 2022

Source: https://www.keypedia.com/records/483/zhejiang-tianyu-pharmaceutical-co-ltd/b3461dfe-7be8-4c56-8864-913e423772ec

> FDA 483 for Zhejiang Tianyu Pharmaceutical Co. Ltd. on March 04, 2022. 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: 2022-03-04
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Zhejiang Tianyu Pharmaceutical Co. Ltd., an API manufacturer, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to adequately investigate impurities, extend investigations to all potentially affected batches, and thoroughly review discrepancies, resulting in the distribution of non-conforming products and customer complaints. Additionally, the inspection revealed inadequate cleaning validation and maintenance of production equipment, posing a risk of contamination.

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## Related Officers

- [Dennis Cantellops Paite](https://www.keypedia.com/people/dennis-cantellops-paite/3336bbb8-8520-4a8a-9085-76e7a55ca773)
- [Laummer Kullan Torres](https://www.keypedia.com/people/laummer-kullan-torres/731852c1-9b11-403e-88d2-e087309bbe34)
- [Supervisory Consumer Safety Officer, China Office](https://www.keypedia.com/people/marcus-a-ray/d394d757-5569-4697-bec1-c24113e29d6f)

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