FDA 483 - UW - Madison Health Sciences IRB - July 25, 2025

The FDA inspected UW - Madison Health Sciences IRB in Madison, WI, and issued a Form 483. The inspection revealed a significant deficiency in the IRB's composition, specifically that it failed to include at least one member whose primary concerns are in nonscientific areas, as evidenced by individuals identified as non-scientific members possessing extensive scientific backgrounds.