FDA 483 - Yung Shin Pharmaceutical Industrial (Kunshan) Co., Ltd. - March 15, 2019

Yung Shin Pharmaceutical Industrial (Kunshan) Co., Ltd., a drug manufacturer in Kunshan, China, was cited for two observations during an FDA inspection. The firm failed to follow written procedures for reporting laboratory deviations and lacked procedures for re-starting or manually discontinuing test runs. Additionally, the company changed suppliers for impurity standards without conducting proper supplier and materials qualification.