FDA 483 - Natalia E. Castillo Almeida, MD - September 11, 2025

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.