FDA 483 - Anthony J. Windebank, M.D., Clinical Investigator - September 19, 2019

Anthony J. Windebank, M.D., a Clinical Investigator in Rochester, MN, was cited for significant deviations from the investigational plan during an FDA inspection from September 16-19, 2019. The inspection revealed failures in following up with subjects who refused further clinic visits, leading to uncaptured adverse events, including two subject deaths. Additionally, a study coordinator improperly assessed adverse and serious adverse events, a responsibility designated solely to a physician.