FDA 483 - Lin Shen - November 17, 2023

During an inspection conducted by the Food and Drug Administration (FDA) from November 13 to November 17, 2023, the clinical investigator Dr. Shen, Lin, MD, located in Beijing, China, received an FDA Form 483 citing observations of non-compliance. The primary observation was a failure to conduct a clinical investigation in accordance with the established investigational plan for the study titled "A Phase 3, Global Multi-Center, Double-Blind, Randomized, Efficacy Study..." concerning metastatic gastric or gastroesophageal junction adenocarcinoma. The inspection noted specific instances where study protocol was not followed. For two subjects, despite positive Hepatitis B antibody (HBV-Ab) screening results, the required HBV-DNA tests were not conducted to rule out active hepatitis infection, which was an explicit exclusion criterion. These subjects were subsequently enrolled, randomized, and administered the investigational product, with one subject later dying. In a third instance, a subject experienced Grade 4 Hypokalemia, an adverse event mandating permanent discontinuation from the study according to the protocol. However, this subject remained in the study and received additional drug infusions. These observations indicate a lapse in adherence to the study protocol and regulatory guidelines governing clinical investigations, potentially impacting patient safety and the integrity of study data. As a result of this FDA 483, Dr. Shen, Lin, MD, is required to respond to these observations by outlining corrective and preventive actions to ensure future compliance with the investigational plan and applicable regulations.