FDA Inspection 1301880 — Genzyme Ireland Limited

Genzyme Ireland Limited — FEI 3003809840

The FDA completed an inspection of Genzyme Ireland Limited on Jan 20, 2026 in Waterford. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). Product area: Biologics.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
Jan 20, 2026
Fiscal Year
2026
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Waterford (Ireland)