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

The FDA inspected Deborah Heart & Lung Center IRB in Browns Mills, NJ, and identified several significant issues. The IRB failed to ensure proper quorum for research reviews and allowed unauthorized individuals to vote during meetings. Additionally, the facility did not follow its written procedures for reporting noncompliance and maintained inadequate meeting minutes, indicating systemic deficiencies in its oversight processes.