FDA 483 - Dr. Norman R. Wasel - April 11, 2014

An FDA inspection of Dr. Norman R. Wasel, a clinical investigator in Edmonton, Alberta, revealed significant deficiencies in clinical study conduct. Observations included a failure to maintain adequate case histories with proper verification of electronic source data and a failure to obtain informed consent from human subjects in accordance with regulations, specifically regarding a revised consent document for study CC-1004-PSOR-009.