FDA Warning Letter — Genzyme Ireland Limited

Case 728681 — FEI 3003809840

The FDA took a Warning Letter action against Genzyme Ireland Limited on June 22, 2026 (Waterford, Ireland). The action was issued by CBER and concerns biologics products. This facility has 5 or more recent FDA inspections on record.

Action Details

Facility
Genzyme Ireland Limited
Date
June 22, 2026
Fiscal Year
2026
Product Type
Biologics
Center
CBER
Location
Waterford (Ireland)