FDA 483 - Kevin L. Winthrop, M.D., M.P.H. - June 14, 2018
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.
An FDA inspection of Health and Science University in Portland, OR, a clinical investigator, identified significant issues with informed consent and adherence to investigational plans. Observations included subjects undergoing study procedures before providing consent, incorrect dispensing of study drugs, and delayed reporting of a serious adverse event. Additionally, the firm failed to maintain adequate case histories, including a lost original informed consent form.
ID · 531eba22-c68c-4754-937a-f39481563b3d