FDA Inspection 1309912 — Benjamin D. Elder, MD, PhD

Benjamin D. Elder, MD, PhD — FEI 3042755766

The FDA completed an inspection of Benjamin D. Elder, MD, PhD on March 27, 2026 in Rochester, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 27, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Rochester, MN (United States)

Additional Details

Clinical Investigator (CI)

Citations

IDCFRDescription
296821 CFR 812.100Investigator non-compliance with agreement/plan/regulations
298121 CFR 812.140(a)(2)(i)Investigator device accountability inadequate