Jonathan Tolins, M.D.November 15, 2024

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

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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.

Company: Jonathan Tolins, M.D.
Inspection Date: November 15, 2024
Product Type: Drugs
Office: Minneapolis District Office
Person: Alanna L. Mussawwir-Bias (Assistant Country Director, Regulatory Specialist BIMO)

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ID · 6a6888f4-0a30-456f-aaf3-742cd218a397