FDA 483 - Louisiana State University Health Sciences Center IRB - July 26, 2023

The FDA inspected Louisiana State University Health Sciences Center, an Institutional Review Board (IRB), and identified significant deficiencies in its operations. Observations included failures to follow written procedures for initial and continuing review, leading to lapsed study approvals and enrollment of subjects during these lapses. The IRB also failed to promptly report instances of noncompliance and study terminations to the FDA, and its meeting minutes lacked sufficient detail regarding administrative closures.