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Genzyme Ireland Limited

FDA Regulatory Profile

Genzyme Ireland Limited has 0 FDA recalls, 10 inspections, 0 510(k) clearances and 1 compliance action on record.

Latest inspection
Jan 20, 2026 · OAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections10Nov 8, 2026Newest record Oct 28, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 20, 2026Waterford, IrelandBiologicsOfficial Action Indicated (OAI)3003809840
Feb 25, 2022Waterford, IrelandDrugsVoluntary Action Indicated (VAI)3003809840
Feb 16, 2018Waterford, IrelandBiologicsNo Action Indicated (NAI)3003809840
Jun 16, 2017Waterford, IrelandDrugsVoluntary Action Indicated (VAI)3003809840
Sep 2, 2015Waterford, IrelandDrugsVoluntary Action Indicated (VAI)3003809840
Sep 26, 2013Waterford, IrelandBiologicsVoluntary Action Indicated (VAI)3003809840
Jul 30, 2013Waterford, IrelandDrugsVoluntary Action Indicated (VAI)3003809840
Sep 30, 2011Waterford, IrelandDrugsVoluntary Action Indicated (VAI)3003809840
Oct 30, 2009Waterford, IrelandDrugsVoluntary Action Indicated (VAI)3003809840
Nov 20, 2008Waterford, IrelandDrugsNo Action Indicated (NAI)3003809840

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3003809840Waterford, Ireland10Jan 20, 2026

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.