FDA 483 - Rowena Punzalan, M.D. - January 15, 2021

Dr. Rowena Punzalan, a Clinical Investigator in Milwaukee, was issued a Form FDA 483 following an inspection. The inspection revealed that the study site failed to report six protocol deviations to the IRB with the annual report, which was a requirement of the IRB standard operating procedures and the study protocol. This indicates a lapse in adherence to the investigational plan and reporting requirements.