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

An FDA inspection was conducted at Satyaprakash N. Makam, M.D. in Munster, IN, from August 20-29, 2012. This for-cause inspection reviewed the clinical investigator's conduct under several clinical study protocols, aligning with Compliance Program 7348.811 for Clinical Investigators and Sponsor Investigators, and referencing 21 CFR 312.60 regarding investigator responsibilities. The inspection identified several significant objectionable conditions, resulting in the issuance of an FDA 483. Key violations included a failure to conduct investigations in accordance with the investigational plans. Specifically, nine subjects were incorrectly stratified in one study, and four subjects were enrolled despite not meeting the required inclusion/exclusion criteria across two studies. Furthermore, the facility demonstrated significant delays in reporting clinical trial endpoints for six subjects and serious adverse events (SAEs) for four subjects, failing to meet specified sponsor and protocol timelines. Other issues involved performing study assessments before obtaining informed consent and consenting subjects to an unapproved addendum. The inspection also noted a failure to report unanticipated problems to the Institutional Review Board (IRB). These observations highlight systemic failures in adherence to protocol, patient eligibility, and timely reporting requirements. The current inspection follows a previous FDA review in 2011, which also identified deficiencies and led to a Warning Letter. The FDA 483 indicates that corrective actions are necessary to ensure compliance with regulatory standards for clinical investigations.