483
Nebraska Methodist Hospital IRBFDA 483 - Nebraska Methodist Hospital IRB - June 12, 2025
Record Details
The FDA inspected Nebraska Methodist Hospital IRB in Omaha, NE, and identified four significant issues. These issues primarily concern the IRB's failure to maintain accurate records, including membership rosters and detailed meeting minutes, and non-compliance with meeting quorum requirements and timely registration updates. The findings indicate deficiencies in the IRB's oversight of clinical research.
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ID · d12512b2-cdc4-423e-8337-2a4e28ff3a18