483
Natalia E. Castillo Almeida, MDFDA 483 - Natalia E. Castillo Almeida, MD - September 11, 2025
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Record Details
The FDA inspected the University of Nebraska Medical Center in Omaha, NE, from September 5-11, 2025, focusing on clinical investigation practices. The inspection revealed a significant failure by the Principal Investigator to report non-serious adverse events to the study sponsor as required by the protocol. This indicates a serious lapse in adherence to clinical trial reporting requirements.
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ID · dfe6427f-bf88-4348-a136-81b573730527