FDA 483 - Michael D. Greenwood, MD - April 11, 2025

Michael D. Greenwood, MD, a clinical investigator in West Fargo, ND, was cited for failing to conduct an investigation according to the signed agreement and investigational plan. Specifically, two serious adverse events (SAEs) were reported late and not recorded in the electronic data system via eCRFs. This indicates issues with adverse event reporting and data management in clinical trial conduct.