FDA 483 - Jeffrey W. Groves, M.D. - April 04, 2019

An FDA inspection of Jeffrey W. Groves, M.D. in Orem, UT, revealed significant deficiencies in a clinical investigation involving a non-significant risk device study. The firm repeatedly failed to ensure the health, welfare, and safety of study subjects, including performing procedures before obtaining proper informed consent. Additionally, the investigator did not evaluate or report possible unanticipated adverse device effects in a timely manner.