FDA 483 - Deborah Heart & Lung Center IRB - July 26, 2021
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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.
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ID · 07072239-3645-46af-b99e-6e7bd8dbf82a