FDA EIR - Martin N. Zaiac - July 14, 2010

An FDA inspection of Principal Investigator Dr. Martin N. Zaiac, MD, located in Miami Beach, FL, was conducted from April 22 to July 14, 2010. This initial, unannounced inspection was prompted by reports from the study sponsor concerning non-compliance with Good Clinical Practice (GCP) and inadequate investigator oversight. These concerns were exacerbated by the tragic death of a study subject, who was discovered to be in her third trimester of pregnancy, using illegal drugs, and suffering from undiagnosed Peripartum Cardiomyopathy—all conditions that should have excluded her from the study. The inspection, carried out under the Bioresearch Monitoring of Clinical Investigators Compliance Program (7348.811), identified numerous significant violations detailed in a six-page FDA-483. Key issues included a critical failure to follow monitoring procedures for ECG evaluations, which contributed to an undetected serious adverse event. Widespread non-compliance with subject enrollment criteria was noted, with individuals admitted despite abnormal lab values, pre-existing conditions, or drug abuse histories. The site also failed to ensure female subjects used appropriate contraception and to withdraw pregnant participants. Additional violations involved inadequate record-keeping, inaccurate data documentation, and delayed reporting of critical adverse events and unanticipated problems to the Institutional Review Board (IRB) and sponsor. Informed consent processes were found to be deficient in terms of language clarity. The sponsor had already terminated the study at this site in November 2009 due to these serious issues. Dr. Zaiac acknowledged the findings and committed to implementing corrective actions and providing a written response.