FDA 483 - Jonathan Tolins, M.D. - November 15, 2024

An FDA inspection of Davita Clinical Research in Minneapolis, MN, identified a significant issue regarding the oversight of a clinical investigation. The clinical investigator failed to ensure that investigational product was administered by protocol-trained dialysis nurses, leading to critical deviations. These deviations included missing required treatments and incorrect dosing of the investigational product for study subjects.