FDA 483 - Avera McKennan Hospital IRB #1 DBA Avera IRB #1 - July 10, 2019

Avera McKennan Hospital IRB #1 DBA Avera IRB #1 in Sioux Falls, SD, received a Form 483 for multiple deficiencies in its Institutional Review Board operations. Key issues include failures in meeting quorum requirements, inadequate meeting minutes, non-adherence to written procedures for research review and roster management, and insufficient record-keeping. These findings indicate significant non-compliance with regulatory requirements for IRB oversight of FDA-regulated research.