FDA 483 - Paul Sorajja, M.D., Clinical Investigator - March 22, 2019

Dr. Paul Sorajja, a clinical investigator in Minneapolis, MN, was cited for two observations during an FDA inspection. The inspection revealed failures in providing subjects with copies of their informed consent forms and significant deviations from the investigational plan. These deviations included unreported adverse events and inadequate staff training for critical study assessments.