FDA 483 - Robyn Sanders, MD - December 17, 2018

An FDA inspection of Robyn Sanders, MD, a clinical investigator in Greensboro, NC, revealed significant deficiencies in the conduct of a clinical study. Observations included failures to obtain proper informed consent from human subjects and a lack of adherence to the investigational plan and the signed statement of investigator. These issues indicate serious non-compliance with regulations governing clinical trials.