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FDA Inspections, Warning Letters and Import Refusals: Ireland

FDA has recorded 589 inspections of firms in Ireland, 10 of them (1.7%) classified OAI. It has issued 13 warning letters to firms there and refused 1,663 import shipments. 31 firms in Ireland are named on FDA import alerts.

OAI (Official Action Indicated) means FDA recommends regulatory and/or administrative action after an inspection. A warning letter is FDA's formal notice of significant violations. An import refusal is a shipment FDA refused entry to the United States.

All countries · Check one supplier with the free FDA compliance check.

By year

The last 10 calendar years (2017 to 2026, 2026 so far). FDA adds classified inspections and posts actions months after they happen, so recent years can still grow.

Ireland: FDA inspections per year 2017: 56 inspections5620172018: 45 inspections4520182019: 45 inspections4520192020: 8 inspections820202021: 6 inspections620212022: 45 inspections4520222023: 36 inspections3620232024: 29 inspections2920242025: 21 inspections2120252026: 6 inspections62026
YearInspectionsOAIOAI shareWarning lettersImport refusals
20266116.7%250
20252100.0%061
20242900.0%089
20233612.8%240
20224512.2%058
2021600.0%043
2020800.0%180
20194500.0%1197
20184500.0%255
20175611.8%148

Latest OAI inspections

DateFacilityProduct type
Jan 20, 2026Genzyme Ireland LimitedBiologics
Nov 16, 2023Abbott VascularDevices
Jun 15, 2022Valeo FoodsFood/Cosmetics
Nov 3, 2017Europharma Concepts LimitedDrugs
May 15, 2014MEDTRONIC IRELANDDevices
May 2, 2014Professor Noel Gerard McElvaneyBiologics
Oct 23, 2013Thermo Fisher Scientific Cork LimitedDrugs
Feb 22, 2012DMC Medical LimitedDevices
Sep 15, 2011Merit Medical Ireland Ltd.Devices
Apr 16, 2010Event Medical LtdDevices

Latest warning letters

DateFirmProduct typeFDA center
Jun 22, 2026Genzyme Ireland LimitedBiologicsCBER
Apr 17, 2026Nicoprof.ComTobaccoCTP
May 31, 2023The Drip Ship (N.I.) LTDTobaccoCTP
May 25, 2023E-Smoke IrelandTobaccoCTP
Mar 26, 2020CARAHEALTHDrugsCDER
Jul 30, 2019Burren Smokehouse Ltd.Food/CosmeticsCFSAN
May 16, 2018Europharma Concepts LimitedDrugsCDER
Mar 29, 2018Oglesby & ButlerTobaccoCTP
Feb 16, 2017Smarter SmokesTobaccoCTP
Dec 7, 2016Viva Vape LimitedTobaccoCTP
Mar 18, 2014Thermo Fisher Scientific Cork LimitedDrugsCDER
May 24, 2012DMC Medical LimitedDevicesCDRH
Jan 30, 2012Merit Medical Ireland Ltd.DevicesCDRH

Search every letter by company with the FDA warning letter search.

Latest import refusals

DateFirmProduct category
Oct 2, 2026Allergan Pharmaceuticals IrelandDrugs and Biologics
Sep 25, 2026Allergan Pharmaceuticals IrelandDrugs and Biologics
Sep 21, 2026Bio-Medical Research LtdDevices
Sep 19, 2026Allergan Pharmaceuticals IrelandDrugs and Biologics
Sep 18, 2026Allergan Pharmaceuticals IrelandDrugs and Biologics
Sep 16, 2026Allergan Pharmaceuticals IrelandDrugs and Biologics
Sep 5, 2026Johnson & Johnson Vision Care Ireland UCDevices
Aug 25, 2026Amo IrelandDevices
Aug 20, 2026Mylan TeorantaDevices
Aug 18, 2026Allergan Pharmaceuticals IrelandDrugs and Biologics
Aug 13, 2026Bausch & Lomb Ireland LimitedDevices
Aug 13, 2026Allergan Pharmaceuticals IrelandDrugs and Biologics
Aug 11, 2026Stafford-Miller LimitedDevices
Aug 11, 2026Stafford-Miller LimitedDevices
Aug 11, 2026Stafford-Miller LimitedDevices
Aug 11, 2026Stafford-Miller LimitedDevices
Aug 11, 2026Stafford-Miller LimitedDevices
Aug 7, 2026LEO Pharma IrelandDrugs and Biologics
Aug 7, 2026Allergan Pharmaceuticals IrelandDrugs and Biologics
Aug 6, 2026DAWNLOUGH TOOLINGDevices
Aug 4, 2026Allergan Pharmaceuticals IrelandDrugs and Biologics
Aug 3, 2026Allergan Pharmaceuticals IrelandDrugs and Biologics
Jul 31, 2026Allergan Pharmaceuticals IrelandDrugs and Biologics
Jul 31, 2026Allergan Pharmaceuticals IrelandDrugs and Biologics
Jul 31, 2026Allergan Pharmaceuticals IrelandDrugs and Biologics

Showing the latest 25 of 1,663.

Firms on FDA import alerts

PublishedFirmImport alertList
Dec 3, 2024EMA AESTHETIC LIMITED89-08red
Aug 16, 2022Emerald Freight Express99-45red
Jul 13, 2020THE OCCLUSION CUFF LTD89-08red
Oct 23, 2019REALTIME TECHNOLOGIES LTD89-08red
Jun 17, 2019Britvic Ireland45-02red
Apr 1, 2019Stiefel Laboratories, Ltd.66-41red
Apr 1, 2019STIEFEL MANUFACTURING (IRELAND)LTD66-41red
Mar 9, 2018Europharma Concepts Limited66-41red
Feb 26, 2018COPPERFIELD EQUINE THERAPY68-19red
Feb 22, 2018Europharma Concepts Limited66-40red
May 10, 2017Nutricia40-05red
Dec 15, 2016BRITVIC45-02red
Sep 8, 2015Hemcon Medical Technologies Europe, Ltd.89-08red
Apr 24, 2015James McDaid & Sons45-02red
Aug 11, 2014Genesis II Church Of Health And Healing66-41red
Sep 30, 2009Clonmel Healthcare Ltd.66-66red
Sep 30, 2009Cranford Ireland Ltd66-66red
Sep 30, 2009Eli Lillu Sa66-66red
Sep 30, 2009Omj Manufacturing Ltd.66-66red
Sep 30, 2009Pfizer Ireland Pharmaceuticals66-66red
Sep 30, 2009Sandilands Limited66-66red
Sep 30, 2009SK Biotek Ireland Ltd.66-66red
Sep 30, 2009Syntex Ireland, Ltd.66-66red
Sep 18, 2009Nestle Ireland Limited45-02red
Sep 16, 2009Amicon Ireland, Ltd.89-04red

Showing the latest 25 of 31.

Most-inspected facilities

FacilityCityInspectionsOAILatest
Pfizer Ireland Pharmaceuticals Unlimited CompanyDublin 22110Dec 15, 2023
Genzyme Ireland LimitedWaterford101Jan 20, 2026
Abbott IrelandCootehill100May 31, 2024
Amgen Technology (Ireland) Unlimited CompanyDun Laoghaire90Jul 25, 2024
NORTON (WATERFORD) LIMITEDWaterford90Jul 29, 2022
Pfizer Ireland Pharmaceuticals Unlimited CompanyNewbridge80Sep 23, 2022
Allergan Pharmaceuticals IrelandWestport80Jun 17, 2022
MEDTRONIC IRELANDGalway81Oct 27, 2016
Eli Lilly S.A. (Irish Branch)Kinsale70Dec 5, 2025
MSD International GmbHClonmel70Feb 17, 2025
Mylan TeorantaInverin70Jul 15, 2022
Forest Laboratories Ireland LimitedDublin 1770Apr 14, 2022
Charles River Laboratories Ireland Ltd.Ballina60Feb 6, 2026
LEO Pharma IrelandDublin 1260Jan 30, 2026
Eurofins Biopharma Product Testing Ireland LimitedDungarvan60Jun 20, 2025

See each facility's Form 483 observations with the FDA 483 search.

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