FDA 483 - Lin Shen - November 17, 2023

An FDA inspection of Shen, Lin, MD, a clinical investigator in Beijing, China, revealed significant deviations from the investigational plan for a Phase 3 study on metastatic gastric or gastroesophageal junction adenocarcinoma. The firm failed to adhere to the study protocol by enrolling subjects who met exclusion criteria and by not discontinuing a subject experiencing a severe adverse event. These findings indicate a lack of adherence to the study's established procedures.