FDA 483 - Paul Sorajja, M.D., Clinical Investigator - August 25, 2023

An FDA inspection of Paul Sorajja, M.D., Clinical Investigator in Minneapolis, MN, revealed a significant issue regarding the conduct of a clinical investigation. The firm failed to capture and timely report all serious adverse events (SAEs) in accordance with the signed agreement, investigational plan, applicable FDA regulations, and IRB conditions. This indicates a serious lapse in patient safety and regulatory compliance during the clinical trial.