FDA 483 - Joseph A. Zadra, MD - May 07, 2021

An FDA inspection of Joseph A. Zadra, MD, a clinical investigator in Barrie, revealed significant deviations from the investigational plan. The firm failed to enroll subjects according to protocol-approved inclusion and exclusion criteria for a clinical trial. Additionally, there were issues with subject dosing not meeting protocol requirements and a failure to conduct required clinical laboratory tests.