FDA Inspection 1275346 — Shaji K. Kumar, M.D.

Shaji K. Kumar, M.D. — FEI 3038166798

The FDA completed an inspection of Shaji K. Kumar, M.D. on June 20, 2025 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: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 20, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Rochester, MN (United States)

Citations

IDCFRDescription
748021 CFR 312.50Ensuring compliance with plan and protocol
753121 CFR 312.62(c)Record retention