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

Source: https://www.keypedia.com/records/483/zhejiang-tianyu-pharmaceutical-co-ltd/3388eb23-b206-45a9-b075-915922728724

> 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: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 was issued to Yongjun Tu, CEO & Chairman of the Board, of Zhejiang Tianyu Pharmaceutical Co. Ltd., located in Taizhou City, Zhejiang 318020, China (FEI Number: 3010972581). The inspection occurred from February 28, 2022, to March 04, 2022.

Three observations were noted:

1.  **Quality System:** The firm failed to extend investigations to other batches potentially associated with a specific failure or deviation. An investigation in July 2020 identified an impurity exceeding specifications in API, affecting at least three batches potentially distributed in the US market. The firm confirmed a higher risk of this impurity in API manufactured before August 2018 but did not extend the investigation to approximately [redacted] batches from 2018 sold for potential US market introduction.

2.  **Quality System:** There was a failure to thoroughly review unexplained discrepancies or components not meeting specifications. A procedure for impurity evaluation during API process development requires evaluation of reagents, synthesis, reactions, and by-products of starting material, intermediate, and final product, which was not thoroughly followed.

3.  **Facilities and Equipment System:** Equipment and utensils were not cleaned or maintained at appropriate intervals to prevent contamination. Specifically, cleaning validation studies were not completed before releasing and delivering [redacted] batches of

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## Related Officers

- [Laurimer X. Kauian-Torres](https://www.keypedia.com/people/laurimer-x-kauian-torres/0be42c7a-e6c6-435e-bf56-74ca7fe413ec)
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- [Dennis Cantellops, Consumer Safety Officer](https://www.keypedia.com/people/dennis-cantellops-consumer-safety-officer/797d73b0-7565-4613-9bc0-806091c80008)

Company: https://www.keypedia.com/companies/zhejiang-tianyu-pharmaceutical-co-ltd/b7ecf3cd-082c-48b5-94e1-8adeba7ce167

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c