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483
•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

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