FDA 483 - Marcia R. Cruz-Correa, M.D., PhD - June 26, 2025

The FDA inspected Pan American Center for Oncology Trials DBA PanOncology Trials, LLC in Rio Piedras, PR, from June 16-26, 2025. The inspection revealed a significant issue where the firm failed to report non-serious adverse events to the sponsor as required by study protocols. Specifically, adverse events documented in source records for multiple subjects across two different clinical trials were not transcribed into the electronic data capture system.