Zhejiang Tianyu Pharmaceutical Co. Ltd.March 4, 2022

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

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Record Details

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.

Company: Zhejiang Tianyu Pharmaceutical Co. Ltd.
Inspection Date: March 4, 2022
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Laurimer Kuilan-Torres
Dennis Cantellops Paite
Marcus A. Ray (Supervisory Consumer Safety Officer, China Office)

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ID · b3461dfe-7be8-4c56-8864-913e423772ec