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FDA Inspections, Warning Letters and Import Refusals: Argentina

FDA has recorded 467 inspections of firms in Argentina, 11 of them (2.4%) classified OAI. It has issued 6 warning letters to firms there and refused 1,149 import shipments. 49 firms in Argentina 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.

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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.

Argentina: FDA inspections per year 2017: 16 inspections1620172018: 45 inspections4520182019: 29 inspections2920192020: 2 inspections220202021: 0 inspections020212022: 11 inspections1120222023: 29 inspections2920232024: 47 inspections4720242025: 8 inspections820252026: 24 inspections242026
YearInspectionsOAIOAI shareWarning lettersImport refusals
20262428.3%022
2025800.0%037
20244712.1%029
20232913.4%138
20221100.0%087
202100018
2020200.0%025
20192900.0%035
20184500.0%025
20171600.0%137

Latest OAI inspections

DateFacilityProduct type
Jun 9, 2026Umicore Argentina S.A.Drugs
May 8, 2026Eriochem SADrugs
Apr 26, 2024Estancia La Paz SAFood/Cosmetics
Jun 9, 2023TERRAGENE S.A.Devices
Dec 8, 2016Glenmark Generics S.A.Drugs
May 13, 2015DULCOR S.A.Food/Cosmetics
Oct 17, 2014F.P. Rubinstein Y Cia SRLDevices
Jul 1, 2014DULCIORA S.A.Food/Cosmetics
Jun 5, 2014Arytza SRLFood/Cosmetics
Sep 3, 2013Pranas S.A.Food/Cosmetics
Jul 18, 2013San Up S.A.Devices

Latest warning letters

DateFirmProduct typeFDA center
Nov 1, 2023TERRAGENE S.A.DevicesCDRH
Dec 28, 2017Investra-24HsDrugsCDER
May 5, 2016F.P. Rubinstein Y Cia SRLDevicesCDRH
Jan 29, 2015F.P. Rubinstein Y Cia SRLDevicesCDRH
Nov 25, 2013San Up S.A.DevicesCDRH
Mar 27, 2013Pranas S.A.Food/CosmeticsCFSAN

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

Latest import refusals

DateFirmProduct category
Oct 8, 2026Glaxosmithkline Argentina S.A.Drugs and Biologics
Sep 17, 2026Odontit SaDevices
Sep 17, 2026Odontit SaDevices
Sep 17, 2026Odontit SaDevices
Sep 17, 2026Odontit SaDevices
Sep 17, 2026Odontit SaDevices
Sep 17, 2026Odontit SaDevices
Sep 17, 2026Odontit SaDevices
Sep 17, 2026Odontit SaDevices
Sep 17, 2026Odontit SaDevices
Sep 17, 2026Odontit SaDevices
Aug 6, 2026LABORATORY POENDrugs and Biologics
Jul 31, 2026CATALENT ANGENTINAHuman Foods
Jul 24, 2026LABORATORIO DE ESPECIALIDADES VEHuman Foods
Jul 24, 2026LABORATORIO DE ESPECIALIDADES VEHuman Foods
Jul 24, 2026NATURAL FOOD SRLHuman Foods
Jul 15, 2026Histo S.A.Devices
Jun 8, 2026Glaxosmithkline Argentina S.A.Drugs and Biologics
Apr 15, 2026COSTAEXPORT S.A.S.Human Foods
Mar 17, 2026NATURAL FOOD SRLHuman Foods
Feb 10, 2026NOVOCAP SADrugs and Biologics
Jan 9, 2026Roemmers LabDrugs and Biologics
Oct 9, 2025Hrenuk S.A.Human Foods
Oct 9, 2025Hrenuk S.A.Human Foods
Oct 9, 2025Hrenuk S.A.Human Foods

Showing the latest 25 of 1,149.

Firms on FDA import alerts

PublishedFirmImport alertList
Oct 26, 2026PRODEMAN S.A.99-19red
Apr 16, 2026COSTAEXPORT SAS99-08red
Apr 16, 2026COSTAEXPORT S.A.S.99-08red
Mar 23, 2026NATURAL FOOD SRL99-08red
Aug 25, 2025Isla De Los Estados S.A.16-105red
Jul 17, 2025Chinfield S.A.68-20red
Apr 4, 2025Segata Y Cia Srl71-04red
Apr 4, 2025Suarko SRL71-04red
Apr 4, 2025Transuniversal S.A.C Y F.71-04red
Apr 3, 2025Proalde S.A.71-04red
Apr 3, 2025San Isidro Pets S.A.71-04red
Apr 1, 2025Euro71-04red
Mar 28, 2025BSP LARTI SA99-08red
Mar 12, 2024MOLECULAR DYNAMICS SAS54-16red
Aug 29, 2023Laboratorio Vetec S.A.68-20red
Dec 16, 2022Wishbone SRL99-19red
Dec 8, 2022Agsof S.A.99-19red
Oct 14, 2022Aerovision S.A99-42red
Oct 14, 2022Buenaventura O. Rodriguez Fabrica De99-42red
Oct 14, 2022Gin Cotton S.A.99-42red
May 18, 2022Digta, S.A.99-46red
May 18, 2022Digta, S.A.99-46red
May 18, 2022Digta, S.A.99-46red
Apr 21, 2022KEYMAR S.R.L99-19red
Nov 15, 2021J L SA99-08red

Showing the latest 25 of 49.

Most-inspected facilities

FacilityCityInspectionsOAILatest
Catalent Argentina S.A.I.C.Buenos Aires60Nov 9, 2023
Instituto Massone S.A.Ciudad Autonoma Buenos Aires50May 22, 2026
Eriochem SAParana51May 8, 2026
Molfino Hermanos S.A.Tio Pujio50Mar 13, 2024
Maprimed S.A.Ciudad Autonoma Buenos Aires40May 15, 2026
Synthon Argentina, SASan Lorenzo40Jul 1, 2022
Umicore Argentina S.A.Pilar31Jun 9, 2026
Patagonik Food S.A.San Carlos De Bolivar30Jun 6, 2024
Vicente Trapani, S.A.Los Nogales30May 17, 2024
Molfino Hermanos S.A.Rafaela30Mar 19, 2024
Veronica S.A.Totoras30Mar 6, 2024
Laboratorios Quimicos S.R.L.Mar Del Plata30Oct 27, 2023
Federico C. Perez Manghi, MDCiudad Autonoma Buenos Aires30Aug 25, 2023
Cepas Argentinas SARivadavia30Aug 8, 2023
Diego Aizenberg, MDCiudad Autonoma Buenos Aires30Jul 25, 2023

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.