FDA Inspections, Warning Letters and Import Refusals: Costa Rica
FDA has recorded 292 inspections of firms in Costa Rica, 16 of them (5.5%) classified OAI. It has issued 11 warning letters to firms there and refused 1,362 import shipments. 72 firms in Costa Rica 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.
Costa Rica: FDA inspections per year
2017: 51 inspections 51 2017 2018: 8 inspections 8 2018 2019: 14 inspections 14 2019 2020: 35 inspections 35 2020 2021: 0 inspections 0 2021 2022: 4 inspections 4 2022 2023: 19 inspections 19 2023 2024: 13 inspections 13 2024 2025: 1 inspections 1 2025 2026: 5 inspections 5 2026
Year Inspections OAI OAI share Warning letters Import refusals
2026 5 0 0.0% 0 113 2025 1 0 0.0% 0 104 2024 13 0 0.0% 1 24 2023 19 1 5.3% 0 93 2022 4 2 50.0% 1 61 2021 0 0 0 20 2020 35 1 2.9% 1 55 2019 14 2 14.3% 1 28 2018 8 0 0.0% 0 58 2017 51 1 2.0% 0 80
Latest OAI inspections
Date Facility Product type
Oct 19, 2023 Aromas Para El Alma S.A. Drugs Jun 9, 2022 Biomerics ATL Costa Rica Devices May 26, 2022 MicroVention Costa Rica S.R.L. Devices Jan 30, 2020 Laboratorios Dentales De Zona Franca, S.A. Devices May 24, 2019 Rainbow Export Processing S.A. Food/Cosmetics Feb 8, 2019 Polimeros Y Servicios S.A. Drugs Apr 7, 2017 INDUSTRIAS EL CARAITO, S.A. Food/Cosmetics Aug 19, 2014 Rainbow Export Processing S.A. Food/Cosmetics Jul 10, 2014 Pimientas Y Especias De Centroamerica S.A. Food/Cosmetics Jul 8, 2014 Pejivallera Tucurrique F&B S.A. Food/Cosmetics Mar 6, 2014 VIANT COSTA RICA, S.A. Devices Feb 28, 2013 DeRoyal Cientifica De Latinoamerica S.R.L. Devices Nov 7, 2012 Comercializadora Segura De Cartago S.S.R. S.A. Food/Cosmetics Oct 20, 2012 AGROINDUSTRIAS MORA S.A Food/Cosmetics Oct 16, 2012 TUBERCULOS DE COSTA RICA, S.A Food/Cosmetics Apr 19, 2012 ICU Medical Costa Rica Ltd. Devices
Latest warning letters
Date Firm Product type FDA center
Sep 10, 2024 Aromas Para El Alma S.A. Drugs CDER Sep 30, 2022 MicroVention Costa Rica S.R.L. Devices CDRH May 15, 2020 Laboratorios Dentales De Zona Franca, S.A. Devices CDRH Aug 22, 2019 Polimeros Y Servicios S.A. Drugs CDER Mar 5, 2015 Rainbow Export Processing S.A. Food/Cosmetics CFSAN Jul 1, 2014 VIANT COSTA RICA, S.A. Devices CDRH Aug 12, 2013 DeRoyal Cientifica De Latinoamerica S.R.L. Devices CDRH Apr 1, 2013 Alimentos Prosalud SA Food/Cosmetics CFSAN Mar 26, 2013 Comercializadora Segura De Cartago S.S.R. S.A. Food/Cosmetics CFSAN Feb 5, 2013 AGROINDUSTRIAS MORA S.A Food/Cosmetics CFSAN Sep 27, 2012 ICU Medical Costa Rica Ltd. Devices CDRH
Search every letter by company with the FDA warning letter search .
Latest import refusals
Date Firm Product category
Oct 8, 2026 Laboratorios Zepol S.A. Drugs and Biologics Oct 8, 2026 Laboratorios Zepol S.A. Drugs and Biologics Oct 7, 2026 CORPORACION DEL VALLE METROPOLITANO S.A. Human Foods Sep 28, 2026 MicroVention Costa Rica S.R.L. Devices Sep 28, 2026 MicroVention Costa Rica S.R.L. Devices Sep 23, 2026 CORPORACION DEL VALLE METROPOLITANO S.A. Human Foods Sep 8, 2026 LAFAGE Drugs and Biologics Sep 8, 2026 GLOBAL PHARMED Drugs and Biologics Sep 8, 2026 CORPORACION DEL VALLE METROPOLITANO S.A. Human Foods Sep 8, 2026 CORPORACION DEL VALLE METROPOLITANO S.A. Human Foods Sep 8, 2026 CORPORACION DEL VALLE METROPOLITANO S.A. Human Foods Sep 8, 2026 CORPORACION DEL VALLE METROPOLITANO S.A. Human Foods Sep 8, 2026 CORPORACION DEL VALLE METROPOLITANO S.A. Human Foods Sep 8, 2026 CORPORACION DEL VALLE METROPOLITANO S.A. Human Foods Sep 8, 2026 CORPORACION DEL VALLE METROPOLITANO S.A. Human Foods Sep 8, 2026 CORPORACION DEL VALLE METROPOLITANO S.A. Human Foods Sep 8, 2026 CORPORACION DEL VALLE METROPOLITANO S.A. Human Foods Sep 4, 2026 CORPORACION DEL VALLE METROPOLITANO S.A. Human Foods Sep 4, 2026 CORPORACION DEL VALLE METROPOLITANO S.A. Human Foods Sep 4, 2026 CORPORACION DEL VALLE METROPOLITANO S.A. Human Foods Sep 4, 2026 CORPORACION DEL VALLE METROPOLITANO S.A. Human Foods Sep 4, 2026 CORPORACION DEL VALLE METROPOLITANO S.A. Human Foods Aug 31, 2026 LABORATORIOS CALOX DE COSTA RICA Drugs and Biologics Aug 12, 2026 CORPORACION DEL VALLE METROPOLITANO S.A. Human Foods Aug 12, 2026 CORPORACION DEL VALLE METROPOLITANO S.A. Human Foods
Showing the latest 25 of 1,362.
Firms on FDA import alerts
Published Firm Import alert List
Nov 10, 2026 INSTANTIA COSTA RICA SOCIEDAD ANONIMA 99-19 red Mar 17, 2026 Tuberculos Ticos SRL 99-05 red Mar 2, 2026 Coprimex S.A. 99-05 red Feb 23, 2026 Vanessa De Los Angeles Laynes Corella 99-05 red Nov 20, 2025 CORPORACION DEL VALLE METROPOLITANO S.A. 33-15 red Oct 28, 2025 Producciones Agricolas Keka Sa 99-05 red Sep 16, 2025 Alimentos Conica S.A. 33-15 red Apr 24, 2025 LAYN FRESH PARADISE, S.A. 99-05 red May 7, 2024 Terrapez S. A. 16-125 green Feb 29, 2024 Aromas Para El Alma S.A. 66-40 red Jun 5, 2023 NICOLE NUNEZ QUIROS 99-05 red May 25, 2023 Agro Jomisar Sociedad Anonima 99-05 red Feb 10, 2023 BARETA SM SRL 99-05 red Jan 3, 2023 Products Varjim Golden Of Costa Rica Limitada 99-05 red Oct 3, 2022 JUAN NUNEZ ABARCA 99-05 red Sep 23, 2022 Agroverde Wj De Linda Vista SA 99-05 red Sep 19, 2022 CULANTRO FRESCO DE COSTA RICA CFC S.A. 99-05 red May 10, 2022 Semafoods S.R.L. 99-05 red Dec 4, 2019 Comercializadora De Productos Tierra Verde R&T Company 99-05 red Nov 21, 2019 3-102-685515 S.A. 99-35 red Oct 31, 2019 TRUCHAS REALES DE COSTA RICA 16-125 green Jul 11, 2019 Polimeros Y Servicios S.A. 66-40 red Jun 22, 2018 Culantreros S.A. 99-05 red Jun 13, 2018 Caribu Importadores Y Exportadora SA 99-05 red Jun 13, 2018 PINERA SUCATO S.A 99-05 red
Showing the latest 25 of 72.
Most-inspected facilities
Facility City Inspections OAI Latest
Abbott Medical Costa Rica Ltda Alajuela 5 0 Apr 25, 2024 Hologic Surgical Products Costa Rica, S.R.L. Alajuela 4 0 Sep 12, 2024 Baxter Productos Medicos, Ltda. Cartago 4 0 May 24, 2018 Boston Scientific De Costa Rica SRL Heredia 4 0 Jan 8, 2016 VIANT COSTA RICA, S.A. Barreal De Heredia 4 1 Aug 6, 2015 Synergy Health AST SRL Alajuela 3 0 May 21, 2026 Sterigenics Costa Rica S.R.L. Alajuela 3 0 Nov 14, 2024 Alimentos Prosalud SA Barranca 3 0 May 24, 2024 Laboratorios Zepol S.A. Curridabat 3 0 Nov 17, 2023 Grupo Pozuelo & PRO GPP, S.A. Ciudad Colon 3 0 Jun 29, 2023 Boston Scientific De Costa Rica SRL El Coyol 3 0 Jun 2, 2022 Corporacion De Desarrollo Agricola Del Monte S.A. - La Cueva Liberia 3 0 Jan 23, 2020 Paradise Ingredients S.A. Cartago 3 0 May 31, 2019 Rainbow Export Processing S.A. Puntarenas 3 2 May 24, 2019 Moog Costa Rica, SRL Alajuela 3 0 Nov 1, 2018
See each facility's Form 483 observations with the FDA 483 search .