FDA 483 - Samuel J. Maiser, M.D., Clinical Investigator - February 11, 2022

An FDA inspection of Hennepin Healthcare in Minneapolis, a clinical investigator, revealed a failure to promptly report adverse effects related to an investigational drug. Specifically, the firm did not report a serious adverse event (SAE) and two non-serious adverse events (AEs) within the required timeframe, indicating issues with their adverse event reporting procedures.