FDA 483 - Deborah Heart & Lung Center IRB - July 26, 2026

An FDA inspection conducted at Deborah Heart & Lung Center IRB from July 15 to July 26, 2021, identified significant issues in the institution's oversight of human research. The findings, documented in an FDA Form 483, primarily concern the IRB's adherence to regulatory requirements for research review. Key observations included instances where the IRB failed to ensure a majority of members, including a nonscientific member, were present and voting during reviews of proposed research. Specifically, multiple meeting minutes showed votes cast by fewer than the required number of voting members, and individuals invited for their expertise were improperly allowed to cast votes. The IRB also did not consistently follow its own written procedures for reporting noncompliance, leading to studies continuing without valid approval due to lapses in continuing review, and failing to issue appropriate notifications. Furthermore, meeting minutes lacked sufficient detail regarding attendance and voting records, with inaccurate reflections of votes and omissions of risk level discussions for device studies. These observations indicate a need for Deborah Heart & Lung Center IRB to implement comprehensive corrective actions to ensure full compliance with federal regulations governing Institutional Review Boards and the protection of human subjects in clinical investigations.