483
Jonathan Tolins, M.D.Jonathan Tolins, M.D. – FDA 483, Nov 15, 2024
Record Details
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.
View Company Profile
ID · 6a6888f4-0a30-456f-aaf3-742cd218a397
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.