FDA 483 - Shammo, Jamile, MD - August 26, 2005

An FDA inspection of Jamile Shammo, MD, a clinical investigator in Chicago, IL, revealed significant deficiencies in the conduct of a clinical investigation. Observations included widespread failure to adhere to the study protocol and investigator statement, delayed reporting of serious adverse events to the sponsor and IRB, and a failure to obtain legally effective informed consent from multiple subjects. These issues indicate serious non-compliance with regulations governing human subject protection and clinical trial conduct.