FDA 483 - Jian Fang - September 22, 2021

An FDA inspection of Jian Feng in Beijing, P.R. China, a clinical investigator, identified significant issues with the maintenance of adequate and accurate case histories. The firm failed to sufficiently document subject eligibility, accurately report adverse events and concomitant medications in electronic case report forms, and consistently submit imaging for review by the Independent Review Committee. These deficiencies indicate a lack of adherence to protocol requirements and robust data integrity practices in clinical investigations.