FDA 483 - Myron Reiff, M.D. - June 27, 2019

An FDA inspection of Myron H. Reiff, M.D., a clinical investigator in Bellflower, CA, revealed significant deviations from the investigational plan and signed statement of investigator. Findings included backdated subject progress notes, lack of physician care for a screen-failure subject, enrollment of subjects who did not meet inclusion/exclusion criteria, and multiple subjects sharing the same caregiver/informant, contrary to the study protocol.