FDA 483 - Avera McKennan Hospital IRB #1 DBA Avera IRB #1 - July 10, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 07b67787-a564-4871-9128-0dc0b9fe48d1