483
UW - Madison Health Sciences IRBUW - Madison Health Sciences IRB – FDA 483, Jul 25, 2025
Record Details
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.
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