FDA 483 - Deborah Heart & Lung Center IRB - July 26, 2021

The FDA inspected Deborah Heart & Lung Center IRB and issued a Form 483 with four observations related to deficiencies in IRB meeting procedures and documentation. The findings include failures to meet quorum requirements for voting, allowing non-rostered individuals to vote, and not adhering to written procedures for reporting noncompliance. Additionally, meeting minutes lacked sufficient detail regarding voting records and risk level discussions for device studies.