483
UW - Madison Health Sciences IRBFDA 483 - UW - Madison Health Sciences IRB - July 25, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
- Person
Open in Dashboard
ID · 04b46ad1-c254-439e-b2b4-3f3ad4673b15