FDA 483 - Asante Health System IRB dba Southern Oregon IRB - January 10, 2025

An FDA inspection of Asante Health System IRB dba Southern Oregon IRB in Medford, OR, revealed a significant procedural lapse. The Institutional Review Board failed to adhere to its own expedited review procedures, specifically by not notifying members of studies and related documents approved via expedited review in 2023. This indicates a breakdown in internal controls for research oversight.