FDA 483 - Hagen F. Kennecke, M.D. - May 02, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 6921252a-5125-4b27-9e38-0c325f0e5792