Meharry Medical College Institutional Review Board – FDA 483, Nov 4, 2021
An FDA inspection of Meharry Medical College Institutional Review Board in Nashville, TN, revealed significant deficiencies in the preparation and maintenance of IRB meeting minutes. The firm failed to maintain sufficient detail regarding attendance, actions, and voting records, and did not adequately document review and approval processes for research protocols. Additionally, the IRB did not consistently follow its own written procedures for conducting initial and continuing research reviews, particularly concerning the documentation of alternate voters and designated reviewers.
- Inspection date
- November 4, 2021
- Product type
- other
ID · 4cd95ed3-6296-40cf-8903-bf1a63470843
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.