FDA 483 - Kevin L. Winthrop, M.D., M.P.H. - June 14, 2018

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.