483
Asante Health System IRB dba Southern Oregon IRBFDA 483 - Asante Health System IRB dba Southern Oregon IRB - January 10, 2025
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Record Details
An FDA inspection of Asante Health System IRB dba Southern Oregon IRB in Medford, OR, revealed a significant procedural lapse. The Institutional Review Board failed to adhere to its own expedited review procedures, specifically by not notifying members of studies and related documents approved via expedited review in 2023. This indicates a breakdown in internal controls for research oversight.
- Inspection Date
- January 10, 2025
- Product Type
- Other
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ID · ea65a53d-093e-41d1-a5cb-fa0c089d9715