FDA EIR - Pablo H. Vivas, M.D. - August 22, 2019

An FDA inspection was conducted at Pablo H. Vivas, M.D., located in Miami Beach, FL, from August 12 to 22, 2019. This for-cause inspection, initiated by a sponsor complaint, focused on two clinical studies where Dr. Vivas served as the principal investigator. The inspection revealed significant deviations from regulatory requirements and study protocols, leading to the issuance of a four-item Form FDA 483. Key violations included a failure to promptly report serious adverse events to the study sponsor and the Institutional Review Board, with one SAE never reported and another reported with significant delay. The investigation also identified inadequate supervision and control over the clinical investigations, evidenced by numerous protocol breaches such as inconsistent testing times, improper use of assessment scales, visits conducted outside of specified windows, and failure to perform required lab procedures. Furthermore, two subjects were enrolled despite not meeting eligibility criteria. The firm also failed to maintain adequate and accurate case histories and investigational drug disposition records. Additionally, essential medical equipment, including the Echo and EKG machines and the weight scale, lacked current calibration records. Staff training on protocols and study materials was also found to be deficient. These findings highlight a systemic lack of adherence to good clinical practice and federal regulations for clinical investigations (21 CFR Part 312). Following the inspection, Dr. Vivas and his study coordinator indicated they would cease all future research studies.