FDA Inspection 1323308 — Regeneron Ireland Designated Activity Company

Regeneron Ireland Designated Activity Company — FEI 3011684330

The FDA completed an inspection of Regeneron Ireland Designated Activity Company on June 13, 2025 in Limerick. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 13, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Limerick (Ireland)

Additional Details

Mutual Recognition Agreement (MRA)