FDA 483 - Sandor A. Romero, MD - February 13, 2018

During an FDA inspection conducted from February 2 to February 13, 2018, the clinical investigator, Sandor A. Romero, located in Cutler Bay, FL, received a Form FDA 483 outlining significant observations. The inspection focused on the Cardiovascular Inflammation Reduction Trial (CIRT). The primary violation identified was the failure to prepare or maintain adequate and accurate case histories, specifically regarding observations and data pertinent to the investigation. The FDA noted that the adequacy and accuracy of source data collected for all study subjects could not be verified because these records were unavailable for inspection. This included critical study data such as adverse event reports, safety laboratory results, physical examination findings, investigational product compliance, and dose titration information. This issue directly contravenes the investigator's commitment made by signing the FDA Form 1572 Statement of Investigator, which outlines responsibilities for conducting clinical investigations in compliance with FDA regulations. While the 483 document itself does not specify immediate required actions, it serves as a formal notification of objectionable conditions. The clinical investigator is expected to address these deficiencies, potentially by submitting a written response detailing corrective actions taken or planned to ensure the integrity and accuracy of clinical trial data, thereby adhering to regulatory standards for clinical research.