FDA 483 - William G. P. Eardley, MSc, MD - July 06, 2018

An FDA inspection of William G. P. Eardley, MSC, MD, FRCSED, Clinical Investigator, revealed significant issues with a clinical investigation. The firm failed to conduct the study according to the investigational plan, including not collecting required data, improperly documenting a serious adverse event, and enrolling an ineligible subject. Additionally, informed consent was not properly obtained or documented for a study subject.