FDA 483 - Rudolph A. Bedford - April 15, 2015

An FDA inspection of Santa Monica Research Institute in Santa Monica, CA, revealed significant deficiencies in conducting clinical investigations and maintaining accurate case histories. The firm failed to adhere to investigational plans, resulting in numerous protocol deviations, including enrolling ineligible subjects and missing required study procedures. Additionally, the institute did not maintain adequate and accurate case histories, with instances of incorrect data and lack of proper authorization for subject treatments.