Zhejiang Tianyu Pharmaceutical Co. Ltd. – FDA 483, Mar 4, 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.
ID · b3461dfe-7be8-4c56-8864-913e423772ec
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