483
Agnesian Healthcare IRBFDA 483 - Agnesian Healthcare IRB - June 17, 2014
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Record Details
An FDA inspection of Agnesian Healthcare IRB in Fond Du Lac, WI, revealed significant deficiencies in its Institutional Review Board operations. The firm failed to promptly notify investigators of research decisions, maintain complete correspondence records, and prepare detailed meeting minutes. These observations highlight systemic issues in the IRB's record-keeping and communication practices.
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ID · 0539a462-475d-42f8-a018-c915f1409044