483
Jackson-Madison County General Hospital IRBJackson-Madison County General Hospital IRB – FDA 483, Nov 26, 2019
Record Details
The FDA inspected Jackson-Madison County General Hospital IRB and found several significant deficiencies. The IRB failed to ensure compliance with regulations for pediatric research, did not follow procedures for reporting noncompliance, and neglected annual continuing review of studies. Additionally, the IRB did not maintain required research documents and its membership lacked sufficient diversity.
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ID · b482a1b7-499e-4b1c-b617-75b9d78f9ca1
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