FDA 483 - Pablo J. Sanchez, M.D., Principal Investigator - October 22, 2012

An FDA inspection of Pablo J. Sanchez, M.D., Principal Investigator, revealed significant deficiencies in the conduct of a clinical investigation. Observations included a failure to ensure IRB approval for study procedures, deviations from the investigational plan regarding specimen handling and concomitant medication recording, and inadequate maintenance of case histories and informed consent documentation. These findings indicate a lack of proper oversight and record-keeping during the study.