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Genzyme Ireland Limited Warning Letter Details

Warning Letter

Genzyme Ireland Limited

Unit 701 IDA Industrial Park Old Kilmeaden Road Co. Waterford X91 TP27 Ireland

Issue DateJune 22, 2026

FEI NumberN/A

Violations3

CountryIreland

Issuing Office

Center for Biologics Evaluation and Research (CBER)

Product Type

Biologics

Status

Open

Subject

CGMP/Deviations/Biologics License Application (BLA)

Genzyme Ireland Limited FDA Warning Letter, June 22, 2026