FDA EIR - Satyaprakash N. Makam, MD - August 29, 2012

An FDA for-cause inspection of Satyaprakash N. Makam, M.D., conducted from August 20-29, 2012, identified significant deviations from regulatory requirements for clinical investigations. This inspection, carried out under Compliance Program 7348.811 for Clinical Investigators and Sponsor Investigators, focused on Dr. Makam's conduct in several clinical study protocols, following a previous 2011 inspection that resulted in a Warning Letter for similar issues.

The recent inspection revealed multiple objectionable conditions, for which an FDA Form 483, Inspectional Observations, was issued. Key violations included the failure to conduct investigations in accordance with the investigational plan, such as inappropriate treatment group stratification for eight subjects and enrollment of four subjects who did not meet inclusion or exclusion criteria. The firm also failed to report study endpoints for six subjects and Serious Adverse Events (SAEs) for four subjects within specified timeframes to the sponsor. Additional observations noted were the performance of study-specific assessments prior to obtaining informed consent, obtaining consent for an unapproved addendum, and failing to report all unanticipated problems to the Institutional Review Board. These findings necessitate prompt corrective actions to ensure patient safety and data integrity in future clinical trials.