FDA 483 - Harold S. Minkowitz, M.D. - April 30, 2018

An FDA inspection of Harold S. Minkowitz, M.D. in Houston, TX, revealed significant deficiencies in the conduct of a Phase III clinical investigation. The firm failed to ensure the investigation was conducted according to the investigational plan, with issues including undocumented sub-investigator training and numerous protocol violations. These violations involved subjects receiving disallowed antiemetic drug therapies.