FDA 483 - Zhejiang Tianyu Pharmaceutical Co. Ltd. - June 08, 2015

Zhejiang Tianyu Pharmaceutical Co., LTD, an API manufacturer in Taizhou City, China, was cited for significant deficiencies during an FDA inspection. Observations included inadequate process controls and sampling procedures for drug substance manufacturing, insufficient statistical approaches for label sampling, and a lack of robust environmental monitoring systems for finished API storage. These issues collectively indicate a lack of assurance regarding product quality and process validation.