FDA 483 - Kenneth N. Sokolski, M.D. - March 08, 2013

An FDA inspection of Kenneth N. Sokolski, M.D. (Clinical Innovations, Inc.) in Costa Mesa, CA, revealed significant deficiencies in the conduct of clinical investigations. The firm failed to adhere to signed investigator statements and investigational plans, leading to numerous protocol deviations across multiple studies. Additionally, the inspection found a failure to maintain accurate case histories, with multiple discrepancies between source documents and electronic case report forms.