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

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.