FDA investigators Stephanie Shapley and Janet White conducted an inspection Jan 25-Feb. 4 to determine if Constantine's activities as a clinical investigator, for an unnamed device study, were within regulations.

Several violations were found including that Constantine failed to ensure the rights, safety and welfare of the subjects under his care. The study, which was conducted at two locations at the university--Institute of Human Virology (IHV) and the Evelyn Jordan Center (EJC) - required that enrolled subjects be between the ages of 18 and 55 years and able to ...

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