FDA 483 - Hagen F. Kennecke, M.D. - May 02, 2024

Hagen F. Kennecke, M.D., a clinical investigator in Portland, OR, was cited for significant deviations from protocol and regulatory requirements during a clinical study. The inspection revealed failures to manage subject safety, including not interrupting study drug dosing or referring a subject to an ophthalmologist despite severe ocular toxicity, and not reporting an adverse event. Additionally, the firm failed to obtain proper informed consent documentation for a study subject.