FDA 483 - George Rodgers - February 22, 2018

An FDA inspection of George Rodgers, a clinical investigator in Salt Lake City, UT, revealed significant deficiencies in the conduct of a clinical investigation. The firm failed to adhere to the investigational plan and protocol, maintain adequate drug records and case histories, ensure proper investigator delegation, and obtain proper informed consent. These issues indicate a lack of control over critical aspects of the clinical trial.