FDA 483 - Enrique S. Hanabergh, MD - June 23, 2021

An FDA inspection of Enrique S. Hanabergh, MD, a clinical investigator in Miami, FL, revealed significant deficiencies in the conduct of two investigational drug trials. Observations included a failure to properly supervise subjects by qualified medical personnel and a failure to maintain adequate and accurate case histories. These issues involved missing lab results, inconsistent subject contact documentation, and a serious lack of adherence to investigational plans and good clinical practice.