FDA 483 - Michael J. Schurr, MD - September 14, 2020

Michael J. Schurr, MD, a clinical investigator in Aurora, CO, received a Form 483 citing two significant observations. The firm failed to promptly report a serious adverse event (SAE) to the medical monitor as per protocol. Additionally, the principal investigator did not provide adequate oversight, leading to unqualified study personnel performing critical study assessments.