483
Robert Wood Johnson U Hosp @ Hamilton IRBRobert Wood Johnson U Hosp @ Hamilton IRB – FDA 483, Dec 22, 2021
Record Details
Robert Wood Johnson U Hosp @ Hamilton IRB was cited for significant deficiencies in its Institutional Review Board (IRB) operations. The inspection revealed failures in updating IRB registration, maintaining complete correspondence with investigators, and ensuring detailed meeting minutes. Additionally, the IRB did not retain required research records for the mandated three-year period.
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ID · 5a58fc23-5a11-45f2-ae33-4f0e87e5ee9b
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