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

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