FDA 483 - Steven W. Boyce, M. D. - September 15, 2011

Steven W. Boyce, M.D., Clinical Investigator, was cited for significant deficiencies in conducting a clinical investigation. The inspection revealed failures related to IRB continuing review approval, improper informed consent documentation, and non-adherence to the investigational protocol. These issues indicate a lack of oversight and control over critical aspects of human subject protection and data integrity.