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FDA Inspections, Warning Letters and Import Refusals: Italy

FDA has recorded 2,371 inspections of firms in Italy, 89 of them (3.8%) classified OAI. It has issued 52 warning letters to firms there and refused 11,130 import shipments. 263 firms in Italy 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.

Italy: FDA inspections per year 2017: 182 inspections18220172018: 271 inspections27120182019: 193 inspections19320192020: 29 inspections2920202021: 18 inspections1820212022: 84 inspections8420222023: 171 inspections17120232024: 214 inspections21420242025: 134 inspections13420252026: 65 inspections652026
YearInspectionsOAIOAI shareWarning lettersImport refusals
20266523.1%0202
202513410.7%1344
202421462.8%3279
202317131.8%0222
20228411.2%0231
20211800.0%0210
20202900.0%0316
201919331.6%2538
201827110.4%1583
201718252.7%3954

Latest OAI inspections

DateFacilityProduct type
Jul 23, 2026BIOPSYBELL S.R.L.Devices
Jul 17, 2026EuroAPI Italy SRLDrugs
Feb 27, 2025Mectronic Medicale S.R.L.Devices
Dec 10, 2024Trivelli Tartufi, SrlFood/Cosmetics
Sep 26, 2024Assut Europe S.P.A.Devices
May 24, 2024Originitalia SRLDrugs
May 24, 2024EUROSIREL S.P.ADrugs
Mar 15, 2024Intercos Europe S.P.ADrugs
Feb 21, 2024Haupt Pharma Latina SrlVeterinary
Oct 27, 2023LabAnalysis Life Science S.R.L.Drugs
May 19, 2023FONA S.R.L.Devices
Mar 16, 2023T-MED SRLDevices
Jul 21, 2022Ralco S.R.L.Devices
Sep 27, 2019Fisiopharma SrlDrugs
Aug 1, 2019Silfradent SrlDevices
Feb 25, 2019DELFINO BATTISTA SRLFood/Cosmetics
Apr 6, 2018Tubilux Pharma SpaDrugs
Jul 4, 2017Istituto Biochimico Italiano Giovanni Lorenzini S.P.A.Drugs
Jun 23, 2017BBCOS SrlDrugs
Jun 1, 2017Gallini SRLDevices
Feb 8, 2017Romeo Ficacci SRLFood/Cosmetics
Jan 31, 2017Forza Vitale Italia S.R.L.Food/Cosmetics
Dec 9, 2016Tubilux Pharma SpaDrugs
Apr 6, 2016ARCO2014Devices
Jan 27, 2016Hans Zipperle, S.P.A.Food/Cosmetics

Showing the latest 25 of 89.

Latest warning letters

DateFirmProduct typeFDA center
Jun 27, 2025Mectronic Medicale S.R.L.DevicesCDRH
Nov 20, 2024EUROSIREL S.P.ADrugsCDER
Nov 7, 2024Originitalia SRLDrugsCDER
Aug 16, 2024Intercos Europe S.P.ADrugsCDER
Oct 28, 2019Silfradent SrlDevicesCDRH
Jul 2, 2019DELFINO BATTISTA SRLFood/CosmeticsCFSAN
Jan 30, 2018Flott S.P.A.Food/CosmeticsCFSAN
Nov 29, 2017BBCOS SrlDrugsCDER
Jul 6, 2017Tubilux Pharma SpaDrugsCDER
Jan 13, 2017ACS Dobfar S.P.A.DrugsCDER
Sep 7, 2016Hans Zipperle, S.P.A.Food/CosmeticsCFSAN
Aug 3, 2016ARCO2014DevicesCDRH
May 20, 2016Latina Pharma S.P.A.DrugsCDER
May 16, 2016ITAL LEMON SPAFood/CosmeticsCFSAN
Apr 20, 2016Azienda Agricola Paul CappelliFood/CosmeticsCFSAN
Nov 23, 2015Herniamesh S.R.LDevicesCDRH
Aug 14, 2015Tecres S.P.A.DevicesCDRH
Jul 29, 2015Cane S.P.A.DevicesCDRH
Apr 8, 2015IMS GIOTTO S.P.A.DevicesCDRH
Mar 31, 2015Avara Liscate Pharmaceutical Services SPADrugsCDER
Feb 13, 2015Multimedical S.R.L.DevicesCDRH
Jul 7, 2014Trifarma S.P.A.DrugsCDER
Apr 30, 2014FRANZESE LA PALMA SRLFood/CosmeticsCFSAN
Apr 18, 2014Pancrazio S.P.A.Food/CosmeticsCFSAN
Jan 23, 2014C.S.O. S.R.L.DevicesCDRH

Showing the latest 25 of 52.

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

Latest import refusals

DateFirmProduct category
Oct 22, 2026PHIMOMED SRLDevices
Oct 15, 2026Intercos Europe S.P.ADevices
Oct 15, 2026Intercos Europe S.P.ADevices
Oct 15, 2026Intercos Europe S.P.ADevices
Oct 15, 2026Intercos Europe S.P.ADevices
Oct 15, 2026Intercos Europe S.P.ADevices
Oct 15, 2026Intercos Europe S.P.ADevices
Oct 15, 2026Intercos Europe S.P.ADevices
Oct 15, 2026Intercos Europe S.P.ADevices
Oct 9, 2026INFNI LABDevices
Oct 8, 2026IBSA Farmaceutici Italia SrlDevices
Oct 8, 2026Sandoz SpaDrugs and Biologics
Oct 8, 2026ALFASIGMA SPADrugs and Biologics
Oct 8, 2026Bruno Farmaceutici SpaDrugs and Biologics
Oct 8, 2026VIATRIS PHARMA SRLHuman Foods
Oct 8, 2026VIATRIS PHARMA SRLDrugs and Biologics
Oct 7, 2026Indaco S.P.A.Human Foods
Oct 2, 2026L MOLTENI & C DEI F ILLI ALITTIDrugs and Biologics
Oct 2, 2026Merck Serono SpaDrugs and Biologics
Oct 2, 2026Eg SpaDrugs and Biologics
Oct 1, 2026Cilione SrlTobacco Products
Oct 1, 2026SAVINI TARTUFI SRLHuman Foods
Sep 30, 2026Doppel Farmaceutici SrlDrugs and Biologics
Sep 28, 2026IBSA Farmaceutici Italia SrlDevices
Sep 25, 2026LABORATORIO DELLA FARMACIA S.R.LDrugs and Biologics

Showing the latest 25 of 11,130.

See every import refusal from Italy.

Firms on FDA import alerts

PublishedFirmImport alertList
Nov 3, 2026ITALIATARTUFI99-38red
Oct 27, 2026Medi16-50red
Sep 16, 2026Conserve Italia Societa Cooperativa Agricola99-39red
Jul 16, 2026Fatro Spa68-19red
Jun 22, 2026MID DOLCIARIA SRL45-02red
Jun 12, 2026Calugi, SRL99-38red
May 19, 2026SPECTRUM MEDICAL SRL89-08red
Apr 10, 2026PEYRANO TORINO SRL99-32red
Apr 9, 2026SKANE KONFETYRER45-02red
Mar 30, 2026Tartufi Bianconi, S.R.L.99-38red
Feb 6, 2026ARMATORE SRL16-119red
Feb 6, 2026Flott S.P.A.16-119red
Feb 6, 2026ROSSO DI MAZARA S.R.L.16-119red
Sep 15, 2025Mado Pasticcerie45-02red
Aug 26, 2025CAP COOPERATIVA ALLEVATORI PUTIGNANO SOC. COOP99-43red
Jul 9, 2025Conserve Italia Arl99-39red
Jun 4, 2025Natco International -Srl-99-45red
Jun 4, 2025Noemi Ceramiche Di Gualdo99-45red
Jun 4, 2025Non Solo Moda S.N.C.99-45red
Jun 4, 2025Pascal Di Sorrentino Carmela & C Sas99-45red
Jun 4, 2025Sa. Bor.99-45red
Jun 4, 2025Sbigoli Terrecotte99-45red
Jun 4, 2025Sergio Campagnolo S.R.L.99-45red
May 27, 2025Antichi Sapori Umbri Di Antinori Petrini Monica & C. S.A.S. Limited Company99-37red
May 27, 2025Giovanni DeSimone Ceremica Majoliche D'arte99-45red

Showing the latest 25 of 263.

Most-inspected facilities

FacilityCityInspectionsOAILatest
Patheon Italia S.P.A.Monza120Feb 10, 2026
Patheon Italia S.P.AFerentino121Jan 30, 2026
Merck Serono S.P.A.Modugno90Sep 26, 2025
Sanofi S.R.L.Anagni90Oct 29, 2024
Indena S.P.A.Settala90Oct 20, 2023
FIS - Fabbrica Italiana Sintetici S.P.A.Montecchio Maggiore80Mar 6, 2026
Catalent Anagni SRLAnagni80Jan 20, 2026
Department Of Defense - Navy (U.S. Naval Hospital Sigonella)Sigonella80Apr 18, 2025
Department Of Defense - Navy (U.S. Naval Hospital Naples)Naples80Apr 15, 2025
Haupt Pharma Latina SrlLatina81Apr 11, 2025
Corden Pharma S.P.A.Caponago80Mar 28, 2025
ACS Dobfar S.P.A.Teramo, San Nicolo A Tordino81Dec 13, 2024
Istituto Biochimico Italiano Giovanni Lorenzini S.P.A.Aprilia81Nov 21, 2024
Cambrex Profarmaco Milano SrlPaullo81Nov 11, 2022
Avara Liscate Pharmaceutical Services SPALiscate71Feb 20, 2026

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.