FDA 483 - Dennis J. Hurwitz, M.D. - April 02, 2013

An FDA inspection of Dennis J. Hurwitz, M.D., Principal Investigator, in Pittsburgh, PA, revealed significant non-compliance with clinical investigation regulations for the Body Tite device study. The firm initiated unapproved protocol deviations, enrolled ineligible subjects, and maintained inadequate informed consent and device accountability records. Additionally, subject case histories were incomplete, adverse events were poorly documented, and required progress reports were not submitted, indicating severe deficiencies in clinical trial conduct and oversight.