FDA 483 - Satyaprakash N. Makam, MD - September 22, 2011

Satyaprakash N. Makam, MD, a clinical investigator in Munster, IN, was inspected by the FDA, revealing significant deficiencies in clinical study conduct. The inspection cited issues primarily related to informed consent procedures, adherence to the investigational plan, and control of investigational devices. These violations indicate a failure to ensure subject protection and data integrity during the study.