483
Somerset Medical Center IRBFDA 483 - Somerset Medical Center IRB - March 11, 2026
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An FDA inspection of Somerset Medical Center IRB identified significant deficiencies in its Institutional Review Board (IRB) operations. The firm failed to consistently ensure that research approvals received the majority vote of members present, frequently not meeting quorum requirements during convened meetings. These issues involved improper use of e-mail voting to approve research and meeting minutes, indicating systemic non-compliance with IRB procedures.
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ID · 6c97064b-5d89-4825-8656-5e4b763c54f7