FDA 483 - Charles Redfern, MD - March 11, 2022

An FDA inspection of Charles Redfern, MD in San Diego, CA, a clinical investigator, revealed a significant observation related to the conduct of a clinical study. The firm failed to follow the investigational plan, specifically regarding the administration and completion of PRO-CTCAE questionnaires and adherence to dose modification protocols for study subjects. This indicates a lack of adherence to study protocols during clinical trials.