FDA 483 - Ryan M. Rich, M.D. - July 29, 2019

An FDA inspection of Ryan M. Rich, M.D., a clinical investigator in Colorado Springs, CO, revealed significant deficiencies in the conduct of an investigational study. The firm failed to follow the investigational plan, including enrolling an ineligible subject and allowing unmasked personnel to perform safety assessments. Additionally, the inspection found a failure to maintain adequate and accurate case histories, with numerous instances of source records being changed without justification.