FDA 483 - Matthew S. Bowdish, M.D., Clinical Investigator - October 27, 2014

Matthew S. Bowdish, M.D., Clinical Investigator, was inspected regarding investigational drug studies in Colorado Springs, CO. The inspection revealed significant deficiencies, including failures to report adverse events to the sponsor and IRB, and enrolling unqualified subjects. Additionally, the firm failed to maintain adequate and accurate case histories, indicating a lack of adherence to regulatory requirements for clinical investigations.