FDA 483 - Edmundowicz, Dr Steven - October 09, 2025

The University of Colorado Denver Hospital received a Form FDA 483 with five observations during an inspection of a clinical study involving a gastric balloon system. The inspection revealed significant issues including non-adherence to the investigational plan, inaccurate and incomplete subject records, and failures in timely reporting to the Institutional Review Board. These findings indicate serious deficiencies in the conduct and oversight of the clinical trial.