FDA 483 - RCRC Independent Review Board (IRB) dba Salus IRB - June 07, 2024

An FDA inspection of RCRC Independent Review Board (IRB) dba Salus IRB in Austin, TX, from June 3-7, 2024, revealed significant deficiencies in the documentation of IRB meeting minutes. The primary concern was the lack of sufficient detail regarding attendance, actions taken, and voting records, indicating issues with record-keeping and oversight of IRB activities.