FDA 483 - William Philip Werschler, MD, FAAD, FAACS - November 29, 2017

An FDA inspection of William P. Werschler, M.D., Clinical Investigator in Spokane, WA, revealed significant deviations from the investigational plan for a significant risk device study. Key issues included failures to follow the study protocol, incomplete device accountability records, and inaccurate subject case histories. Additionally, informed consent was not properly documented for a large number of subjects.