FDA 483 - Richard F. McGuire, Jr., MD - August 06, 2021

The FDA inspected Richard F. McGuire, Jr., MD, a clinical investigator in La Mirada, CA, from August 2-6, 2021. The inspection revealed a severe lack of routine oversight by the Principal Investigator during clinical studies, leading to widespread falsification of study documents. Specifically, the Study Coordinator made fraudulent signatures on behalf of the investigator and performed duties for which they were not qualified, such as reviewing ECG tracings and conducting physical exams.