FDA 483 - Kasia Osadzinska, MD - June 15, 2021

The FDA inspected Cornerstone Research Institute (Kasia Osadzinska, MD) in Altamonte Springs, FL, regarding a Phase 3 clinical trial (Protocol HTX-011-302). The inspection revealed that the investigation was not conducted in accordance with the investigational plan. Specifically, subjects received rescue medication doses exceeding protocol limits and ineligible subjects were enrolled into the study.