Robert M. Haws, M.D.September 4, 2020

FDA 483 - Robert M. Haws, M.D. - September 04, 2020

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Record Details

An FDA inspection of Robert M. Haws, M.D. in Marshfield, WI, identified a significant deviation from an investigational plan. The clinical investigator failed to adhere to the study protocol for dose escalation in a clinical trial, leading to potential subject safety concerns. This non-compliance involved multiple subjects and specific protocol sections related to study design and drug dose adjustments.

Company: Robert M. Haws, M.D.
Inspection Date: September 4, 2020
Product Type: Drugs
Office: Minneapolis District Office
Person: Denise L. Burosh (Bioresearch Monitoring Specialis)

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ID · 906bb9d6-60f7-4348-9277-bdaa950d6681