FDA 483 - Jon B. Cole, MD - April 26, 2019

Dr. Jon B. Cole, a clinical investigator in Minneapolis, was cited for significant non-compliance during an FDA inspection of his clinical investigations. The inspection revealed failures to submit Investigational New Drug applications, obtain legally effective informed consent, and conduct investigations according to the approved plan. Additionally, issues included untimely reporting of serious adverse events, inadequate study monitoring, and insufficient investigational drug disposition records.