FDA 483 - Orlando L. Rivero, MD - June 08, 2023

An FDA inspection of Orlando L. Rivero, MD, a clinical investigator in Miami, revealed two significant observations related to the conduct of a clinical study. The firm failed to obtain proper informed consent for one subject and did not conduct the investigation in accordance with the investigational plan, specifically regarding access to unblinded records. These issues indicate deficiencies in human subject protection and adherence to study protocols.