FDA 483 - Paul A. Goepfert, MD. - November 20, 2020

Paul A. Goepfert, MD, Principal Investigator, was inspected regarding a clinical study and found to have significant deficiencies in maintaining adequate case histories. The firm failed to obtain proper documentation for COVID-19 screening tests, lacked sufficient laboratory records for immunogenicity sample processing, and had incomplete subject eligibility information regarding participation in other clinical studies. These issues indicate serious concerns with data integrity and adherence to study protocols.