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Facility profile

Genzyme Ireland Limited

Testing & analysis · Drug product manufacturing · Waterford · Ireland

FDA recordFDA directory updated Jul 22, 2026Profile not yet claimed12 registered company locations
Potential fit

Listed operations

The U.S. Food and Drug Administration (FDA) record lists broad activities for this site. Confirm specific services and availability directly.

AnalysisLabelManufacturePackRelabelRepackSterilize
Due diligence

Regulatory record at a glance

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Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 22, 2026

Latest matched inspection
Voluntary action indicated (VAI)

Feb 25, 2022 · FDA documented observations for voluntary correction.

Matched compliance actions
Warning Letter · Jun 2026

Within five years · review the action and follow-up.

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Shows

Registration status and a latest matched voluntary action indicated inspection.

Doesn’t show

Exact services, availability, capacity, pricing, or overall quality.

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Method and source details
View full inspection and compliance history10 inspection records

FDA inspection history

10 records, Nov 2008 – Feb 2022 · 2 NAI · 8 VAI · 0 OAI

DateClassProject areaCitationsFY
Feb 25, 2022VAIDrug Quality Assurance2022
Feb 16, 2018NAIBlood and Blood Products2018
Jun 16, 2017VAIDrug Quality Assurance2017
Sep 2, 2015VAIDrug Quality Assurance2015
Sep 2, 2015VAIBlood and Blood Products2015
Sep 26, 2013VAIBlood and Blood Products2013
Jul 30, 2013VAIDrug Quality Assurance2013
Sep 30, 2011VAIDrug Quality Assurance2011
Oct 30, 2009VAIDrug Quality Assurance2010
Nov 20, 2008NAIDrug Quality Assurance2009

No action indicated (NAI) · Voluntary action indicated (VAI) · Official action indicated (OAI)

Matched compliance actions

Jun 22, 2026Warning Letter · CBER
Unclaimed profile

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Genzyme Ireland Limited — Waterford · Ireland · Labverity