FDA 483 - David M Francyk - October 20, 2017

An FDA inspection of David M. Francyk, DO, Clinical Investigator in Phoenix, AZ, revealed significant deficiencies in the conduct of clinical investigations. Observations included failure to follow the investigational plan and exclusion criteria, inadequate maintenance of case histories, and conducting study procedures prior to obtaining informed consent from subjects. These issues indicate a serious lack of adherence to regulatory requirements and protocol.