483
Howard University Institutional Review BoardFDA 483 - Howard University Institutional Review Board - May 19, 2022
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.
Record Details
The FDA issued a Form 483 to Howard University Institutional Review Board following an inspection from May 11-19, 2022. The inspection revealed a significant deficiency in the preparation of IRB meeting minutes, specifically regarding the accurate documentation of attendance. Discrepancies were noted between the number of members recorded as present and the number participating in votes across multiple meetings.
Open in Dashboard
ID · 4ab72752-1ef1-481e-87f6-b872a14277a2