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FDA Inspections, Warning Letters and Import Refusals: United Kingdom

FDA has recorded 1,585 inspections of firms in United Kingdom, 85 of them (5.4%) classified OAI. It has issued 156 warning letters to firms there and refused 16,933 import shipments. 340 firms in United Kingdom 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.

United Kingdom: FDA inspections per year 2017: 153 inspections15320172018: 119 inspections11920182019: 102 inspections10220192020: 24 inspections2420202021: 27 inspections2720212022: 69 inspections6920222023: 109 inspections10920232024: 83 inspections8320242025: 74 inspections7420252026: 51 inspections512026
YearInspectionsOAIOAI shareWarning lettersImport refusals
20265112.0%12511
20257468.1%3546
20248367.2%5387
202310954.6%6392
20226945.8%1504
20212727.4%4395
202024312.5%11332
201910254.9%12451
201811943.4%13575
201715332.0%13453

Latest OAI inspections

DateFacilityProduct type
Feb 20, 2026Orean Personal Care LtdDrugs
Oct 23, 2025Sheffield Precision Medical LimitedDevices
Oct 10, 2025Mizkan Euro Ltd. (Middleton)Food/Cosmetics
Sep 19, 2025A. Nelson & Co., Ltd.Drugs
Jul 3, 2025Caltag Medsystems LtdDevices
Jan 23, 2025XPO HEALTH LIMITEDDevices
Jan 9, 2025Wardray Premise LtdDevices
Aug 8, 2024Randox Laboratories LimitedDevices
Aug 1, 2024SUREPULSE MEDICAL LTDDevices
May 24, 2024Shalini Iyengar, MBBSBiologics
Mar 29, 2024Norbrook Laboratories LimitedVeterinary
Mar 15, 2024Orean Personal Care LtdDrugs
Mar 14, 2024Kenex (Electro-Medical) Ltd.Devices
Dec 14, 2023Amplivox LtdDevices
Dec 13, 2023Michelson Diagnostics LtdDevices
Sep 15, 2023McCallum Manufacturing LimitedDrugs
Jun 8, 2023City Technology Ltd.Devices
Apr 27, 2023Spectrum Medical Ltd.Devices
Oct 21, 2022Ernest Jackson & Co., Ltd.Drugs
Aug 11, 2022Medivance Instruments Ltd.Devices
May 20, 2022Clive Ballard, M.D.Drugs
Apr 21, 2022Nemaura Pharma LimitedDevices
May 25, 2021UK Health Security AgencyDrugs
May 21, 2021Porton Biopharma LimitedDrugs
Feb 14, 2020Smoked Salmon UnlimitedFood/Cosmetics

Showing the latest 25 of 85.

Latest warning letters

DateFirmProduct typeFDA center
Oct 2, 2026Originalc.Co.UkTobaccoCTP
Jul 17, 2026Mkpodplug.Co.UkTobaccoCTP
Jul 10, 2026Indejuicevapestore.Co.UkTobaccoCTP
Jul 2, 2026ELFC UKTobaccoCTP
Jul 2, 2026Snusblast.Co.UkTobaccoCTP
Jun 17, 2026HERBAL DERMALS LTDDrugsCDER
Jun 17, 2026TELOS TRADINGDrugsCDER
May 19, 2026Pouchline.ComTobaccoCTP
May 19, 2026Snusguys.ComTobaccoCTP
Feb 27, 2026SnusHaven LtdTobaccoCTP
Feb 27, 2026Thesnuslife.ComTobaccoCTP
Feb 12, 2026A. Nelson & Co., Ltd.DrugsCDER
Nov 14, 2025Lowkeydis.ComTobaccoCTP
Aug 1, 2025Confer WithDrugsCDER
Mar 21, 2025Thejuicewarehouse.Co.UkTobaccoCTP
Dec 6, 2024Randox Laboratories LimitedDevicesCDRH
Aug 29, 2024Orean Personal Care LtdDrugsCDER
Apr 29, 2024Kitchen Garden Foods LtdFood/CosmeticsCFSAN
Mar 29, 2024Coombe Castle International Ltd.Food/CosmeticsCFSAN
Mar 25, 2024Mahoney Property LtdDrugsCDER
Nov 16, 2023Lingkey Co LtdTobaccoCTP
Sep 29, 2023Spectrum Medical Ltd.DevicesCDRH
Sep 7, 2023Caltag Medsystems LtdDevicesCDRH
Jun 16, 2023Phoenix Vaping Ltd.TobaccoCTP
Jun 16, 2023Selon CompanyTobaccoCTP

Showing the latest 25 of 156.

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

Latest import refusals

DateFirmProduct category
Oct 22, 2026Ipsen BioPharm LtdDrugs and Biologics
Oct 22, 2026TEVA UK LIMITEDDrugs and Biologics
Oct 22, 2026ARAMEX- TRANSITDrugs and Biologics
Oct 22, 2026ARAMEX- TRANSITDrugs and Biologics
Oct 21, 2026AvonDevices
Oct 21, 2026MORIRE SMITHDevices
Oct 21, 2026Kendal Nutricare Ltd.Human Foods
Oct 21, 2026Kendal Nutricare Ltd.Human Foods
Oct 21, 2026Kendal Nutricare Ltd.Human Foods
Oct 21, 2026TAYLORDFBA LTDHuman Foods
Oct 21, 2026TAYLORSFBA LTDHuman Foods
Oct 15, 2026Kendal Nutricare Ltd.Human Foods
Oct 14, 2026MERLIN VET EXPORT LTDDrugs and Biologics
Oct 9, 2026Thornton & Ross LtdCosmetics
Oct 9, 2026Cradlecrest T/A Wells OffshoreDevices
Oct 9, 2026Coopervision Manufacturing, Ltd.Devices
Oct 8, 2026BRUSHBABY LTDDrugs and Biologics
Oct 8, 2026CIPLA EU LTDDrugs and Biologics
Oct 8, 2026Swizzels Matlow LimitedHuman Foods
Oct 8, 2026GlaxosmithklineDrugs and Biologics
Oct 8, 2026MERLIN VET EXPORT LTDDrugs and Biologics
Oct 5, 2026TRIDOTS UKTobacco Products
Oct 5, 2026TRIDOTS UKTobacco Products
Oct 5, 2026NEAFS UK LTDTobacco Products
Oct 2, 2026HALEON UK TRADINGDrugs and Biologics

Showing the latest 25 of 16,933.

See every import refusal from United Kingdom.

Firms on FDA import alerts

PublishedFirmImport alertList
May 19, 2026Galloway Lodge Ltd99-37red
May 19, 2026NEAFS UK LTD98-06red
May 19, 2026Spectrum Medical Ltd.89-08red
Apr 24, 2026Life Science Health Ltd.66-41red
Apr 6, 2026Mizkan Euro Ltd. (Middleton)99-38red
Mar 23, 2026Pharmhub Pharmacy66-57red
Mar 5, 2026Body Clock Health Care Ltd89-08red
Jan 16, 2026TRIDOTS UK98-06red
Dec 5, 2025Caltag Medsystems Ltd89-04red
Sep 15, 2025GYROGEAR LIMITED89-08red
Sep 3, 2025Nestle - Halifax Plant99-39red
Jul 17, 2025DAYE (ANNE'S DAY LTD)89-08red
Jun 6, 2025Wayman Ceramics99-45red
Jun 6, 2025Wellbeck China99-45red
Jun 5, 2025Timney-Fowler Ltd99-45red
Jun 4, 2025Raesuervic Ceramics - Packett Street99-45red
Jun 4, 2025Regency99-45red
May 27, 2025Kevin Green Raku Ceramics99-45red
May 21, 2025Crown Trent China Limited99-45red
May 19, 2025Astbury Ltd99-45red
May 15, 2025AR Interiors99-45red
Apr 21, 2025A. Nelson & Co., Ltd.68-19red
Jan 23, 2025Chrysalis Health & Beauty Business Solutions Ltd66-41red
Jan 23, 2025HEALTH NUTRITION LIMITED66-41red
Oct 21, 2024Futura Medical Developments Limited99-34red

Showing the latest 25 of 340.

Most-inspected facilities

FacilityCityInspectionsOAILatest
SHS International, Ltd.Liverpool130Apr 24, 2026
Norbrook Laboratories LimitedNewry135Mar 29, 2024
Bioreliance Ltd.Glasgow110May 13, 2026
Seqirus Vaccines LimitedLiverpool90Jun 10, 2025
MedImmune U.K. LimitedLiverpool90May 16, 2024
Patheon UK LimitedSwindon80Jul 7, 2026
Charles River Laboratories Edinburgh Ltd.Tranent80Jun 11, 2026
Almac Pharma Services LimitedCraigavon80Nov 28, 2025
Dept. Of The Air Force - 48Th Medical Group/SGSALBrandon80Aug 4, 2025
Reading Scientific Services LtdReading81Jun 16, 2025
Ipsen BioPharm LtdWrexham80May 22, 2025
Kindeva Drug Delivery LimitedLoughborough80Mar 14, 2025
Glaxo Operations UK LimitedWare80Dec 6, 2024
Catalent U.K. Swindon Zydis LimitedSwindon80Oct 10, 2024
Protherics UK LimitedLlandysul80Aug 13, 2024

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.