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

An FDA inspection of Satyaprakash N. Makam, M.D., in Munster, IN, was conducted from August 20-29, 2012, under Compliance Program 7348.811 for Clinical Investigators. This was the second inspection, following a 2011 inspection that resulted in an FDA 483 and Warning Letter. The current inspection identified significant violations of investigational plan adherence, summarized in an FDA Form 483. Main issues included incorrect treatment group stratification for nine of sixteen subjects in one clinical study. Four subjects were improperly enrolled due to not meeting inclusion/exclusion criteria across two studies. There were systemic failures in timely reporting, with six subjects experiencing delayed endpoint reporting and four subjects experiencing delayed Serious Adverse Event (SAE) reporting to the sponsor. Additionally, study-specific assessments were performed prior to obtaining informed consent, subjects were consented to an unapproved addendum, and unanticipated problems were not consistently reported to the Institutional Review Board (IRB). These observations indicate a recurring pattern of non-compliance with regulatory requirements, specifically 21 CFR 312.60 concerning investigator responsibilities. Corrective actions are required to address these findings and ensure proper conduct of clinical investigations.