FDA Inspections, Warning Letters and Import Refusals: Portugal
FDA has recorded 272 inspections of firms in Portugal, 8 of them (2.9%) classified OAI. It has issued 10 warning letters to firms there and refused 1,083 import shipments. 60 firms in Portugal 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.
Portugal: FDA inspections per year
2017: 24 inspections 24 2017 2018: 16 inspections 16 2018 2019: 28 inspections 28 2019 2020: 2 inspections 2 2020 2021: 1 inspections 1 2021 2022: 10 inspections 10 2022 2023: 23 inspections 23 2023 2024: 25 inspections 25 2024 2025: 13 inspections 13 2025 2026: 15 inspections 15 2026
Year Inspections OAI OAI share Warning letters Import refusals
2026 15 0 0.0% 0 177 2025 13 1 7.7% 0 191 2024 25 1 4.0% 3 35 2023 23 0 0.0% 1 11 2022 10 0 0.0% 0 56 2021 1 0 0.0% 0 12 2020 2 0 0.0% 0 43 2019 28 0 0.0% 0 65 2018 16 0 0.0% 1 33 2017 24 2 8.3% 1 51
Latest OAI inspections
Date Facility Product type
Jan 14, 2025 Porttable Produtos Alimentares, Lda. Food/Cosmetics Jan 26, 2024 FANCYSTAGE, UNIPESSOAL, LDA. Drugs Feb 7, 2017 Fabrica De Conservas A Poveira, S.A. Food/Cosmetics Feb 7, 2017 A Tremoceira Estela Da Piedade Lda Food/Cosmetics Feb 12, 2016 Antonio Mineiro E Andrade, Lda Food/Cosmetics Mar 28, 2014 Hikma Farmaceutica, (Portugal) S.A. Drugs Feb 18, 2014 Brites Vaz & Irmaos Food/Cosmetics Feb 12, 2014 Gialmar - Produtos Alimentares SA Food/Cosmetics
Latest warning letters
Date Firm Product type FDA center
Dec 18, 2024 COFISA - Conservas De Peixe Da Figueira, S.A. Food/Cosmetics CFSAN Aug 30, 2024 100Misterios, LDA Food/Cosmetics CFSAN Jun 4, 2024 FANCYSTAGE, UNIPESSOAL, LDA. Drugs CDER Aug 3, 2023 FANCYSTAGE, UNIPESSOAL, LDA. Drugs CDER May 3, 2018 Ramirez & Ca. (Filhos) Food/Cosmetics CFSAN May 5, 2017 Fabrica De Conservas A Poveira, S.A. Food/Cosmetics CFSAN Jun 28, 2016 Antonio Mineiro E Andrade, Lda Food/Cosmetics CFSAN Jul 16, 2015 Http://Www.Cigars-Habanos.Com Tobacco CTP Oct 21, 2014 Hikma Farmaceutica, (Portugal) S.A. Drugs CDER Oct 2, 2014 Gialmar - Produtos Alimentares SA Food/Cosmetics CFSAN
Search every letter by company with the FDA warning letter search .
Latest import refusals
Date Firm Product category
Oct 21, 2026 MESOSYSTEM S.A. Drugs and Biologics Oct 20, 2026 CARE TO BEAUTY, LDA Human Foods Oct 9, 2026 COFISA - Conservas De Peixe Da Figueira, S.A. Human Foods Sep 22, 2026 EIGHTJUICE - LABORATORIO NUTRACERUTICO, LDA Human Foods Sep 22, 2026 EIGHTJUICE - LABORATORIO NUTRACERUTICO, LDA Human Foods Sep 22, 2026 EIGHTJUICE - LABORATORIO NUTRACERUTICO, LDA Human Foods Sep 22, 2026 EIGHTJUICE - LABORATORIO NUTRACERUTICO, LDA Human Foods Sep 22, 2026 LABIALFARMA Human Foods Sep 16, 2026 HIKMA FARMACEUTICA (PORTUGAL) SA Drugs and Biologics Sep 16, 2026 Uniqueijo - Uniao De Cooperativas Agricolas De Lacticinios De Sao Jorge, UCRL Human Foods Sep 16, 2026 Uniqueijo - Uniao De Cooperativas Agricolas De Lacticinios De Sao Jorge, UCRL Human Foods Sep 16, 2026 Uniqueijo - Uniao De Cooperativas Agricolas De Lacticinios De Sao Jorge, UCRL Human Foods Sep 16, 2026 Uniqueijo - Uniao De Cooperativas Agricolas De Lacticinios De Sao Jorge, UCRL Human Foods Sep 16, 2026 Uniqueijo - Uniao De Cooperativas Agricolas De Lacticinios De Sao Jorge, UCRL Human Foods Sep 16, 2026 CARE TO BEAUTY, LDA Drugs and Biologics Sep 16, 2026 CARE TO BEAUTY, LDA Drugs and Biologics Sep 16, 2026 CARE TO BEAUTY, LDA Drugs and Biologics Sep 16, 2026 CARE TO BEAUTY, LDA Drugs and Biologics Sep 16, 2026 CARE TO BEAUTY, LDA Drugs and Biologics Sep 16, 2026 CARE TO BEAUTY, LDA Drugs and Biologics Sep 16, 2026 CARE TO BEAUTY, LDA Drugs and Biologics Sep 16, 2026 CARE TO BEAUTY, LDA Drugs and Biologics Sep 16, 2026 CARE TO BEAUTY, LDA Drugs and Biologics Sep 16, 2026 CARE TO BEAUTY, LDA Drugs and Biologics Sep 16, 2026 CARE TO BEAUTY, LDA Drugs and Biologics
Showing the latest 25 of 1,083.
Firms on FDA import alerts
Published Firm Import alert List
Nov 6, 2026 Rui Rebelo 45-02 red Sep 11, 2026 EIGHTJUICE - LABORATORIO NUTRACERUTICO, LDA 66-41 red Aug 27, 2025 FERNANDO & SIMOES, LDA 99-43 red Aug 27, 2025 Finisterra Cooperativa De Lacticinios Do Topo 99-43 red Aug 26, 2025 Companhia Dos Acores, Comercio De Produtos Alimentares, LDA 99-43 red Aug 26, 2025 Companhia Dos Acores C. Prod. Ali.Lda. 99-43 red Aug 26, 2025 COOPERATIVA AGRICOLA DE LACTICINIOS DOS LOURAIS 99-43 red Jun 4, 2025 Molde Falancas LDA 99-45 red Jun 4, 2025 Obrarte Ceramica, Lda 99-45 red May 21, 2025 Faiancas Neto & Gomes, Lda. 99-45 red May 1, 2025 Porttable Produtos Alimentares, Lda. 99-37 red Apr 3, 2025 Luso Petisco Produtos Carneos, S.A., 71-04 red Jan 7, 2025 Mesosystem Sa 66-41 red Jan 7, 2025 MESOSYSTEM S.A. 66-41 red Nov 7, 2024 BIOCOL PHARMA, LDA 99-39 red May 8, 2023 FANCYSTAGE, UNIPESSOAL, LDA. 66-40 red Jun 15, 2021 Brasmar - Comercio De Produtos Alimentares, S.A. 16-39 red Mar 30, 2021 Ilda Maria Alves Eduardo Henriques 12-10 red Jun 26, 2019 Fernando Manuel Pereira Sousa Company 45-02 red Jun 6, 2019 HERO PORTUGAL 99-39 red Jan 2, 2019 Lusomedicamenta Sociedade Tecnica Farmaceutica S.A 66-41 red Jan 12, 2018 ERU (Aka Fabrica De Queijo-Eru) Portuguesa, Lda. 12-10 red Jan 12, 2018 Uniqueijo - Uniao De Cooperativas Agricolas De Lacticinios De Sao Jorge, UCRL 12-10 red Jun 19, 2017 L.C.I. C/O Epifutur Lda 53-06 red Jan 10, 2017 Almerinda & Filhos Lda. 99-22 red
Showing the latest 25 of 60.
Most-inspected facilities
Facility City Inspections OAI Latest
Hovione FarmaCiencia SA Loures 11 0 Oct 24, 2024 Hikma Farmaceutica, (Portugal) S.A. Terrugem Snt 9 1 Apr 21, 2023 Bluepharma Industria Farmaceutica, S.A. Coimbra 7 0 May 9, 2025 CIPAN - Companhia Industrial Produtora De Antibioticos SA Castanheira Do Ribatejo 6 0 Feb 9, 2023 Bial Portela & Ca. S.A. South Mamede Do Coronado 5 0 May 6, 2022 Tecnimede-Sociedade Tecnico-Medicinal, S.A. Dois Portos 3 0 Sep 11, 2025 Lusomedicamenta Sociedade Tecnica Farmaceutica S.A Barcarena 3 0 Oct 18, 2024 COFISA - Conservas De Peixe Da Figueira, S.A. Figueira Da Foz 3 0 Apr 12, 2024 Teresa P.M. Coelho, M.D. Porto 3 0 May 12, 2023 Macarico, S. A. Praia De Mira 3 0 Apr 18, 2023 Conservas Portugal Norte, Lda. Matosinhos 3 0 Apr 5, 2023 Teka Portugal S.A. Ilhavo 3 0 Nov 11, 2022 Antonio Mineiro E Andrade, Lda Ribeira Grande 3 1 Jul 28, 2022 Cofaco Acores, Industria De Conservas S.A. Rabo De Peixe 3 0 Jul 27, 2022 Queijo Saloio Industria De Lacticinios, S.A. Ponte Do Rol 3 0 Nov 14, 2019
See each facility's Form 483 observations with the FDA 483 search .