FDA 483 - Kurt Barnhart, MD - December 15, 2017

An FDA inspection of Kurt Barnhart, MD, a clinical investigator in Philadelphia, revealed significant deficiencies in the conduct of clinical investigations. Observations included failures to adhere to the signed statement of investigator, such as continuing a subject on exclusionary medication and enrolling subjects without complete lab results. Additionally, the firm failed to meet general requirements for informed consent by not re-consenting subjects to an updated form that included new risk factors.