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FDA Inspections, Warning Letters and Import Refusals: Spain

FDA has recorded 1,478 inspections of firms in Spain, 51 of them (3.5%) classified OAI. It has issued 31 warning letters to firms there and refused 4,942 import shipments. 199 firms in Spain 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.

Spain: FDA inspections per year 2017: 109 inspections10920172018: 174 inspections17420182019: 98 inspections9820192020: 16 inspections1620202021: 24 inspections2420212022: 89 inspections8920222023: 89 inspections8920232024: 102 inspections10220242025: 81 inspections8120252026: 64 inspections642026
YearInspectionsOAIOAI shareWarning lettersImport refusals
20266411.6%1146
20258122.5%0193
202410243.9%2169
20238911.1%0159
20228933.4%2129
20212400.0%0129
20201600.0%099
20199844.1%3142
201817442.3%2237
201710921.8%0184

Latest OAI inspections

DateFacilityProduct type
Apr 7, 2026Pujado Solano S.A.Food/Cosmetics
Jun 10, 2025REAL CONSERVERA ESPANOLA, S.L.Food/Cosmetics
Jan 24, 2025SEDECAL SADevices
Oct 29, 2024Gastraval S.L.Food/Cosmetics
Sep 27, 2024Anfele, S.A.Food/Cosmetics
May 21, 2024BACALAO GIRALDO, S.L.U.Food/Cosmetics
Apr 19, 2024AJL Ophthalmic S.ADevices
Jun 23, 2023Laboratorio Reig Jofre S.A.Drugs
Sep 9, 2022Laboratorio Genove SADrugs
Feb 16, 2022Conservas Ortiz S.A.Food/Cosmetics
Feb 4, 2022Bioiberica, SAUDrugs
Dec 19, 2019Desarrollo E Investigacion Medica Aragonesa SLDevices
Oct 10, 2019Global Medical Technology SLDevices
Sep 5, 2019Esteve Quimica, S.A.Drugs
Apr 5, 2019Laboratorio Reig Jofre, S.A.Drugs
Jul 9, 2018Salazones Garre, S.L.Food/Cosmetics
Jun 14, 2018Proandre SLDrugs
Mar 22, 2018Leventon S. A. U.Devices
Mar 7, 2018Laboratorios TegorFood/Cosmetics
Sep 22, 2017Miguel Arean E Hijos, S.L.Food/Cosmetics
May 31, 2017Casmara Cosmetics, S.A.Drugs
May 6, 2016Interquim S.A.Drugs
Apr 21, 2016Purac BioQuimica, S.A.Drugs
Apr 19, 2016Alesan Artesanos SLFood/Cosmetics
Apr 12, 2016Conservas Antonio Alonso S.A.Food/Cosmetics

Showing the latest 25 of 51.

Latest warning letters

DateFirmProduct typeFDA center
Oct 8, 2026SNUSLJUS SLTobaccoCTP
Sep 30, 2024BACALAO GIRALDO, S.L.U.Food/CosmeticsCFSAN
Mar 27, 2024Jolca SAFood/CosmeticsCFSAN
Jun 30, 2022Bioiberica, SAUDrugsCDER
Jun 17, 2022Conservas Ortiz S.A.Food/CosmeticsCFSAN
Dec 20, 2019Global Medical Technology SLDevicesCDRH
Feb 15, 2019Proandre SLDrugsCDER
Jan 28, 2019Salazones Garre, S.L.Food/CosmeticsCFSAN
Sep 5, 2018Leventon S. A. U.DevicesCDRH
Feb 12, 2018Casmara Cosmetics, S.A.DrugsCDER
Dec 15, 2016NATURA BISSE INTERNATIONAL SADrugsCDER
Nov 22, 2016Interquim S.A.DrugsCDER
Oct 17, 2016Alfonso Garcia Lopez, S.A.Food/CosmeticsCFSAN
Nov 14, 2014Balfego And Balfego, SLFood/CosmeticsCFSAN
Nov 6, 2014Salazones Garre, S.L.Food/CosmeticsCFSAN
Nov 5, 2014Agrovillaserra, S.L.Food/CosmeticsCFSAN
Oct 15, 2014Desarrollo E Investigacion Medica Aragonesa SLDevicesCDRH
Aug 8, 2014Www.E-Tobaccos.ComTobaccoCTP
Jun 2, 2014Wacker Leon SL.DrugsCDER
Jan 23, 2014Cotton High Tech S.L.( D/Ba COHITECH)DevicesCDRH
Aug 26, 2013Jabones Pardo S.A.DrugsCDER
Jun 20, 2012Ercros S.A.DrugsCDER
Jun 11, 2012Cal VallsFood/CosmeticsCFSAN
Jun 5, 2012Hijos De Carlos Albo S. L.Food/CosmeticsCFSAN
Apr 24, 2012Tedec-Meiji Farma, S.A.DrugsCDER

Showing the latest 25 of 31.

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

Latest import refusals

DateFirmProduct category
Oct 22, 2026CANTABRIA LABSDrugs and Biologics
Oct 20, 2026LABORATORIOS LACER S.ADrugs and Biologics
Oct 20, 2026GRUPO ENDRA FOODS, S.L.Human Foods
Oct 20, 2026GRUPO ENDRA FOODS, S.L.Human Foods
Oct 14, 2026Vidal Golosinas SAHuman Foods
Oct 13, 2026ESHIKA IMPEXCosmetics
Oct 13, 2026ESHIKA IMPEXCosmetics
Oct 13, 2026ESHIKA IMPEXCosmetics
Oct 13, 2026ESHIKA IMPEXCosmetics
Oct 9, 2026Simildiet S.L. LaboratoriosCosmetics
Oct 8, 2026Cyndea PharmaDrugs and Biologics
Oct 8, 2026SISNEO BIOSCIENCE S.L.Devices
Oct 2, 2026SANHIGIA SLDevices
Sep 30, 2026Industrias Farmaceuticas Almirall S.A.Drugs and Biologics
Sep 25, 2026CMC MEDICAL DEVICES & DRUGS, S.LDrugs and Biologics
Sep 23, 2026ANATOMICAL GEOMETRY SLDevices
Sep 22, 2026LABORATOIRES QUINTON INTERNATIONHuman Foods
Sep 18, 2026SESDERMA SLDrugs and Biologics
Sep 18, 2026SESDERMA SLCosmetics
Sep 18, 2026SESDERMA SLCosmetics
Sep 17, 2026Labiana Life Science, S.A.Drugs and Biologics
Sep 15, 2026Vidal Golosinas SAHuman Foods
Sep 15, 2026Vidal Golosinas SAHuman Foods
Sep 15, 2026Vidal Golosinas SAHuman Foods
Sep 15, 2026Vidal Golosinas SAHuman Foods

Showing the latest 25 of 4,942.

Firms on FDA import alerts

PublishedFirmImport alertList
Oct 1, 2026Pujado Solano S.A.16-120red
Sep 29, 2026Vidal Golosinas SA45-02red
Aug 27, 2026MOYSEAFOOD, S.A.99-47red
Aug 26, 2026MOYSEAFOOD, S.A.99-39red
Jun 12, 2026UNOLAB MANUFACTURING AVDA66-41red
Apr 20, 2026BEAUNIVATIONS SL53-17red
Apr 16, 2026BEAUNIVATIONS SL53-06red
Jan 6, 2026REAL CONSERVERA ESPANOLA, S.L.16-120red
Dec 1, 2025BELLROS TRADING LTD N0372787B99-34red
Aug 26, 2025SPANISH CHEESE SL99-43red
Jun 30, 2025Famar Health Care Services Madrid S.A.66-41red
Jun 4, 2025Nivehica99-45red
Jun 4, 2025OBJETOS DE ARTE TOLEDANO99-45red
Jun 4, 2025Puente Del Arzobispo99-45red
May 27, 2025KARIM ORTIZ BEN BOUAZZA99-45red
May 21, 2025Fajalauza Fabrica De Ceramica H De M Morales99-45red
May 20, 2025Ceramica Jacinto Castillo Castro99-45red
May 20, 2025Ceramicas A.Majo99-45red
May 12, 2025La Casera Central99-45red
May 1, 2025La Casera Central99-39red
Apr 30, 2025Anfele, S.A.16-120red
Apr 25, 2025AGINA PIPERRAK99-38red
Apr 9, 2025Gastraval S.L.16-120red
Apr 3, 2025Sedealca71-04red
Apr 3, 2025VELET.COOP.V66-41red

Showing the latest 25 of 199.

Most-inspected facilities

FacilityCityInspectionsOAILatest
U.S. Navy Medicine Readiness And Training Command Rota SpainRota80Aug 7, 2025
Laboratorios Leon Farma SAUVillaquilambre80Jul 11, 2025
Curia Spain SAUBoecillo80Feb 27, 2023
Laboratorios Grifols, S.A.Parets Del Valles70Jun 19, 2026
Esteve Quimica S.A.Banyeres Del Penedes70Oct 24, 2025
ROVI Pharma Industrial Services S.A.Madrid70Jun 10, 2025
Bioiberica, SAUPalafolls71Sep 20, 2024
Interquim S.A.Sant Cugat Del Valles71Sep 6, 2024
Wyeth Farma SASan Sebastian De Los Reyes70Sep 27, 2019
Berlimed, S.A.Alcala De Henares60Feb 11, 2026
Esteve Quimica, S.A.Celra60Sep 18, 2025
Moehs Cantabra, S.L.Polanco61Jul 17, 2025
Quimica Sintetica, SAAlcala De Henares60Apr 23, 2025
Urquima, SaSant Fost De Campsentelles60Jan 31, 2025
Laboratorios Liconsa SAUAzuqueca De Henares60Jan 17, 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.