FDA 483 - SCL Health IRB - November 07, 2019

An FDA inspection of SCL Health IRB in Broomfield, CO, identified significant deficiencies in their Institutional Review Board (IRB) record-keeping practices. The firm failed to maintain detailed and accurate IRB meeting minutes, specifically regarding member attendance and voting records. Additionally, the inspection revealed that the list of IRB members was not properly maintained or updated, lacking essential identifying information.