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

An FDA inspection of Sandor A. Romero, MD in Cutler Bay, FL, a clinical investigator, revealed a significant issue regarding the maintenance of adequate and accurate case histories. Specifically, the firm failed to provide source data for verification, which was committed to by signing the FDA 1572 Statement of Investigator. This deficiency impacts the integrity and accuracy of study data, including adverse event reporting and investigational product compliance.