FDA 483 - University of North Texas Health Science Center-IRB - August 28, 2025

The FDA inspected the University of North Texas Health Science Center-IRB in Fort Worth, TX, and issued a Form 483. The inspection revealed a significant deficiency in record keeping, specifically that IRB membership lists were not adequately maintained for the required three years, with previous member information being deleted rather than retained. This indicates non-compliance with record retention regulations for research oversight.