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My DashboardInspection TrackerWarning LettersGenzyme Ireland Limited

All Warning Letters

Genzyme Ireland Limited

Warning LetterOpen

Unit 701 IDA Industrial Park Old Kilmeaden Road Co. Waterford X91 TP27 IrelandIssued Jun 22, 2026Center for Biologics Evaluation and Research (CBER)

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations3

Issue DateJun 22, 2026

Product TypeBiologics

StatusOpen

Letter Details

Firm: Genzyme Ireland Limited
Location: Unit 701 IDA Industrial Park Old Kilmeaden Road Co. Waterford X91 TP27 Ireland
FEI Number: N/A
Country: Ireland
Issue Date: June 22, 2026
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