FDA 483 - Benjamin D. Elder, MD, PhD - March 27, 2026

An FDA inspection of Benjamin D. Elder, MD, PhD, a clinical investigator in Rochester, MN, revealed two significant observations. The investigation was not conducted according to the investigational plan, specifically regarding required physical exams for enrolled subjects. Additionally, records for the use of an investigational device were found to be inaccurate and incomplete, lacking crucial lot number documentation.