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

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.