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FDA Inspections, Warning Letters and Import Refusals: Brazil

FDA has recorded 579 inspections of firms in Brazil, 22 of them (3.8%) classified OAI. It has issued 14 warning letters to firms there and refused 6,413 import shipments. 137 firms in Brazil 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.

Brazil: FDA inspections per year 2017: 42 inspections4220172018: 47 inspections4720182019: 40 inspections4020192020: 2 inspections220202021: 0 inspections020212022: 9 inspections920222023: 41 inspections4120232024: 39 inspections3920242025: 45 inspections4520252026: 31 inspections312026
YearInspectionsOAIOAI shareWarning lettersImport refusals
20263100.0%1345
20254536.7%0392
20243925.1%0196
20234100.0%0206
20229111.1%1176
2021000253
2020200.0%0189
20194025.0%0358
20184736.4%0212
20174200.0%1290

Latest OAI inspections

DateFacilityProduct type
Sep 3, 2025Greco & Guerreiro - SP Envase LTDAFood/Cosmetics
Aug 21, 2025ECO FRESH INDUSTRIA E COMERCIO DE ALIMENTOS LTDAFood/Cosmetics
May 27, 2025Coopertiva Vinicola Aurora LTDAFood/Cosmetics
Aug 13, 2024Riclan S.A.Food/Cosmetics
May 9, 2024RIO BIOFARMA BRASIL LTDADevices
Jul 22, 2022Nortec Quimica SADrugs
Dec 6, 2019Cartibras Beneficiadora De Produtos Animais LtdaDrugs
Sep 13, 2019Apis Vida Industria E Comercio Produtos Farmaceuticos LtdaFood/Cosmetics
Aug 28, 2018Antibioticos Do Brasil LtdaDrugs
May 18, 2018Baxter Hospitalar LtdaDrugs
May 10, 2018Pietrobon E Cia Ltda.Drugs
Apr 27, 2016Antibioticos Do Brasil LtdaDrugs
Apr 15, 2016Mappel Industria De Embalagens S.A.Drugs
Mar 3, 2016Lima & Pergher Industria E Comercio S/ADrugs
Nov 17, 2015FROOTY COMERCIO E INDUSTRIA DE ALIMENTOS S/AFood/Cosmetics
Oct 19, 2015Atum Do Brasil Captura Industria E Comercio Ltda.Food/Cosmetics
Mar 27, 2015Chocolates Garoto LTDAFood/Cosmetics
Mar 20, 2015Pamonharia Do Aguinaldo Ltda.Food/Cosmetics
Mar 11, 2015Apis Vida Industria E Comercio Produtos Farmaceuticos LtdaFood/Cosmetics
Apr 29, 2011Norte Pesca S/AFood/Cosmetics
Feb 24, 2011Laboratorios B. Braun S.A.Devices
Nov 6, 2008Antibioticos Do Brasil LtdaDrugs

Latest warning letters

DateFirmProduct typeFDA center
May 22, 2026Aeroflex Industria De Aerosol LtdaDrugsCDER
Dec 8, 2022Nortec Quimica SADrugsCDER
Aug 4, 2017Mb Industria Cirurgica LtdaDevicesCDRH
Dec 8, 2016Antibioticos Do Brasil LtdaDrugsCDER
Sep 12, 2016Mappel Industria De Embalagens S.A.DrugsCDER
Aug 26, 2016Lima & Pergher Industria E Comercio S/ADrugsCDER
Mar 18, 2016Atum Do Brasil Captura Industria E Comercio Ltda.Food/CosmeticsCFSAN
Aug 27, 2015Apis Vida Industria E Comercio Produtos Farmaceuticos LtdaFood/CosmeticsCFSAN
Aug 3, 2015Chocolates Garoto LTDAFood/CosmeticsCFSAN
Jul 21, 2015Pamonharia Do Aguinaldo Ltda.Food/CosmeticsCFSAN
Aug 8, 2014Greiner Bio One Brasil Produtos Medicos Hospitalares Ltda.DevicesCDRH
Jul 26, 2011Laboratorios B. Braun S.A.DevicesCDRH
Apr 5, 2010Zipmed MesooneDrugsCDER
Jul 24, 2009Antibioticos Do Brasil LtdaDrugsCDER

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

Latest import refusals

DateFirmProduct category
Oct 21, 2026Upper Dog Comercial LTDAAnimal Feed
Oct 21, 2026Upper Dog Comercial LTDAAnimal Feed
Oct 21, 2026DROGA CLARA FARMACIA DE MANIPULADrugs and Biologics
Oct 21, 2026DROGA CLARA FARMACIA DE MANIPULADrugs and Biologics
Oct 21, 2026Bayer S.A.Drugs and Biologics
Oct 21, 2026ACHE LABORATORIOS FARMACEUTICOSDrugs and Biologics
Oct 21, 2026MEEK S.A.Drugs and Biologics
Oct 21, 2026SANOFI MEDLEY FARMACEUTICADrugs and Biologics
Oct 21, 2026Upper Dog Comercial LTDAAnimal Feed
Oct 21, 2026Upper Dog Comercial LTDAAnimal Feed
Oct 15, 2026Amafil Ind. Com. Alimentos LtdaHuman Foods
Oct 15, 2026Amafil Ind. Com. Alimentos LtdaHuman Foods
Oct 13, 2026Maricultura Pescados Com. Imp. E Exp. Ltda.Human Foods
Oct 13, 2026Maricultura Pescados Com. Imp. E Exp. Ltda.Human Foods
Oct 13, 2026Maricultura Pescados Com. Imp. E Exp. Ltda.Human Foods
Oct 13, 2026Maricultura Pescados Com. Imp. E Exp. Ltda.Human Foods
Oct 13, 2026Caliman Agricola SAHuman Foods
Oct 7, 2026Pagnier Cimercio LTDATobacco Products
Oct 7, 2026Pagnier Cimercio LTDATobacco Products
Oct 7, 2026Pagnier Cimercio LTDATobacco Products
Oct 7, 2026Pagnier Cimercio LTDATobacco Products
Oct 7, 2026Pagnier Cimercio LTDATobacco Products
Oct 7, 2026Pagnier Cimercio LTDATobacco Products
Oct 7, 2026Pagnier Cimercio LTDATobacco Products
Oct 7, 2026Pagnier Cimercio LTDATobacco Products

Showing the latest 25 of 6,413.

See every import refusal from Brazil.

Firms on FDA import alerts

PublishedFirmImport alertList
Oct 20, 2026Caliman Agricola SA99-05red
May 15, 2026Vitalis Industria De Alimentos Ltda99-32red
Apr 14, 2026D.S. Comercio De Produtos Agricolas Ltda99-05red
Jan 6, 2026DaColonia Alimentos Naturais Ltda99-43red
Nov 20, 2025G'Nutre Produtos Alimenticios Ltda.45-02red
Nov 20, 2025Greco & Guerreiro - SP Envase LTDA45-02red
Nov 4, 2025ECO FRESH INDUSTRIA E COMERCIO DE ALIMENTOS LTDA45-02red
Nov 4, 2025Floryl Agricola Ltda99-08red
Aug 28, 2025Coopertiva Vinicola Aurora LTDA20-07red
Jun 30, 2025Distillerie Stock Do Brasil Ltda99-38red
Jun 4, 2025Riclan S.A.54-14red
Jun 2, 2025Riclan S.A.54-14red
May 13, 2025Quanto Mais Import And Export99-45red
May 1, 2025Quanto Mais Import And Export99-39red
Apr 4, 2025Upper Dog Comercial LTDA71-04red
Apr 3, 2025Pet Mania Comercio Internacional LTDA71-04red
Apr 3, 2025Petropolis Industria E Comercio Ltda71-04red
Apr 2, 2025Jbs S/A71-04red
Apr 2, 2025Kelco Sul Alimentos E Racoes Ltda.71-04red
Apr 1, 2025De Ville Artigos Para Animais71-04red
Mar 31, 2025Anabe Industria E Comercio De Proteinas Ltda.71-04red
Mar 31, 2025BERTIN LTDA71-04red
Mar 31, 2025Brasil Kirin Industria De Bebidas Ltda.71-04red
Mar 19, 2025EMPORIO DOCES NEROPOLIS LTDA99-32red
Mar 19, 2025Fabrica De Balas Pirapora Ltda ME99-32red

Showing the latest 25 of 137.

Most-inspected facilities

FacilityCityInspectionsOAILatest
Antibioticos Do Brasil LtdaCosmopolis73Dec 13, 2024
Anidro Do Brasil Extracoes S.A.Parnaiba50Nov 15, 2024
Uniao Quimica Farmaceutica Nacional SAGuarulhos50Aug 9, 2023
Boehringer Ingelheim Animal Health Do Brasil Ltda.Paulinia50Jun 15, 2023
ITF Chemical LtdaCamacari50Sep 9, 2022
SIGVARIS DO BRASIL IND. E COM. LTDAJundiai40Mar 7, 2024
Phibro Saude Animal Internacional Ltda.Guarulhos40Jul 28, 2023
Atum Do Brasil Captura Industria E Comercio Ltda.Itapemirim41May 16, 2023
Dori Alimentos S.A.Marilia30Sep 13, 2024
Ajinomoto Do Brasil Industria E Comercio De Alimentos LtdaLimeira30Aug 11, 2023
Nortec Quimica SADuque De Caxias31Aug 4, 2023
Sucocitrico Cutrale Ltda.Araraquara30Jul 21, 2023
Becton Dickinson Industrias Cirurgicas, LTDA.Juiz De Fora30Dec 15, 2022
Sourcetech Quimica Ltda.Pindamonhangaba30Jun 3, 2022
Icefruit Industria E Comercio De Alimentos, Ltda.Tatui30Dec 10, 2019

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.