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FDA Inspections, Warning Letters and Import Refusals: Ecuador

FDA has recorded 293 inspections of firms in Ecuador, 25 of them (8.5%) classified OAI. It has issued 14 warning letters to firms there and refused 1,910 import shipments. 181 firms in Ecuador 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.

Ecuador: FDA inspections per year 2017: 0 inspections020172018: 27 inspections2720182019: 38 inspections3820192020: 1 inspections120202021: 0 inspections020212022: 9 inspections920222023: 16 inspections1620232024: 0 inspections020242025: 5 inspections520252026: 8 inspections82026
YearInspectionsOAIOAI shareWarning lettersImport refusals
2026800.0%075
2025500.0%071
202400276
202316318.8%160
2022900.0%062
202100049
2020100.0%049
20193812.6%041
20182700.0%052
201700168

Latest OAI inspections

DateFacilityProduct type
Dec 14, 2023AUSTROFOOD S.A.S.Food/Cosmetics
Jul 28, 2023Empacadora Bilbo S.A.Food/Cosmetics
Apr 24, 2023Gondi S.A.Food/Cosmetics
Jun 4, 2019MIYAQUIL SAFood/Cosmetics
Nov 10, 2016MIYAQUIL SAFood/Cosmetics
Oct 16, 2015Empacreci SAFood/Cosmetics
Jun 3, 2014Star Company S.A.Food/Cosmetics
Apr 16, 2013Galatuna S.A.Food/Cosmetics
Apr 5, 2013Good FishFood/Cosmetics
Apr 4, 2013EMPACADORA DIAMANTEFood/Cosmetics
Feb 7, 2012Pesnusan Cia LtdaFood/Cosmetics
Aug 16, 2011Peslasa S.A.Food/Cosmetics
Aug 12, 2011EMPREDE S.A.Food/Cosmetics
Aug 10, 2011NEGOCIOS INDUSTRIALES REAL S-.A (NIRSA)Food/Cosmetics
Dec 8, 2010Ricaberto S.A.Food/Cosmetics
Dec 3, 2010Ariegra S.A.Food/Cosmetics
Dec 1, 2010Exofrut/Hacienda Rapallo (Farm)Food/Cosmetics
Dec 1, 2010Bresson S.AFood/Cosmetics
May 19, 2010Alprojansa Alimentos Procesados De JaibaFood/Cosmetics
May 14, 2010Peslasa S.A.Food/Cosmetics
May 14, 2010Estar CAFood/Cosmetics
May 11, 2010Pesnusan Cia LtdaFood/Cosmetics
May 7, 2010EMPREDE S.A.Food/Cosmetics
May 7, 2010Oceaninvest S.A.Food/Cosmetics
Mar 31, 2009EMPACADORA DIAMANTEFood/Cosmetics

Latest warning letters

DateFirmProduct typeFDA center
Aug 9, 2024AUSTROFOOD S.A.S.Food/CosmeticsCFSAN
Feb 9, 2024Empacadora Bilbo S.A.Food/CosmeticsCFSAN
Nov 2, 2023Gondi S.A.Food/CosmeticsCFSAN
Mar 16, 2017MIYAQUIL SAFood/CosmeticsCFSAN
Feb 4, 2016Proceconsa S.A. Procesadora Continental De Alimentos S.A.Food/CosmeticsCFSAN
Nov 24, 2014Crimasa Criaderos De Mariscos S. A.Food/CosmeticsCFSAN
Sep 24, 2014Star Company S.A.Food/CosmeticsCFSAN
Sep 4, 2014StarkistFood/CosmeticsCFSAN
Nov 23, 2013EMPACADORA DIAMANTEFood/CosmeticsCFSAN
Aug 16, 2013Good FishFood/CosmeticsCFSAN
Jan 23, 2012NEGOCIOS INDUSTRIALES REAL S-.A (NIRSA)Food/CosmeticsCFSAN
Oct 22, 2010Pesnusan Cia LtdaFood/CosmeticsCFSAN
Aug 19, 2010Peslasa S.A.Food/CosmeticsCFSAN
Aug 10, 2010EMPREDE S.A.Food/CosmeticsCFSAN

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

Latest import refusals

DateFirmProduct category
Oct 8, 2026Tecnandina S.A.Drugs and Biologics
Sep 18, 2026Industrial Pesquera Santa Priscila S.A. (Factory 2)Human Foods
Sep 8, 2026CARVAGU S SHuman Foods
Sep 3, 2026GAMBAS DEL PACIFICOHuman Foods
Aug 3, 2026EXPOTUNA S.A.Human Foods
Aug 3, 2026EXPOTUNA S.A.Human Foods
Aug 3, 2026EXPOTUNA S.A.Human Foods
Jul 10, 2026EXPOTUNA S.A.Human Foods
Jul 8, 2026EXPOTUNA S.A.Human Foods
Jul 8, 2026EXPOTUNA S.A.Human Foods
Jul 8, 2026EXPOTUNA S.A.Human Foods
Jul 8, 2026EXPOTUNA S.A.Human Foods
Jul 6, 2026LAMBAC S.A.Human Foods
Jul 2, 2026LABORATORIOS LABMACHuman Foods
Jul 2, 2026LABORATORIOS LABMACHuman Foods
Jul 2, 2026LABORATORIOS LABMACHuman Foods
Jul 2, 2026LABORATORIOS LABMACHuman Foods
Jul 2, 2026EAGLECUADORDrugs and Biologics
Jul 2, 2026LAMBAC S.A.Human Foods
Jun 23, 2026MUNOZ PIN ANDERSON ROBERTOHuman Foods
Jun 23, 2026MUNOZ PIN ANDERSON ROBERTOHuman Foods
Jun 23, 2026MUNOZ PIN ANDERSON ROBERTOHuman Foods
Jun 23, 2026MUNOZ PIN ANDERSON ROBERTOHuman Foods
Jun 22, 2026EXPOTUNA S.A.Human Foods
Jun 22, 2026EXPOTUNA S.A.Human Foods

Showing the latest 25 of 1,910.

Firms on FDA import alerts

PublishedFirmImport alertList
Nov 10, 2026Fgenterprise S.A.99-08red
Jun 12, 2026RAMESHI SNACK S.A.S.45-02red
May 7, 2026EXPOTUNA S.A.16-81red
Mar 2, 2026Compania Agricola Ganadera S.A. Chongon99-05red
Mar 2, 2026Compania Agricola Ganadera S.A. Hacienda El Chaparral99-05red
Feb 12, 2026Jimbofoods S.A.S.99-19red
Dec 23, 2025VASQUEZ LOPEZ EDGAR VINICIO12-10red
Sep 22, 2025FABIAN ERNESTO VILLARUEL SANCHEZ99-05red
Jul 28, 2025Empacadora Coral Del Pacifico EMCOPAC S.A.16-05green
Jun 4, 2025Mythos Native Art99-45red
Jun 2, 2025ECUARURUKUNA99-05red
Apr 16, 2025LABORATORIO GENESIS LABGENESIS CIA. LTDA.66-41red
Oct 29, 2024Lubia AMerica Perez Santos45-02red
Aug 15, 2024Sagacomex99-43red
Aug 5, 2024ASESORA ASESORES INTEGRALES DELAGRO ASINAGRO SAS99-05red
Jul 2, 2024Empacadora Bilbo S.A.16-120red
Jun 24, 2024Pablo Francisco Beltran Sanchez99-39red
Jun 6, 2024Pablo Francisco Beltran Sanchez66-41red
Jun 6, 2024Sagacomex12-10red
Jun 3, 2024Sanchez Obando Alexander Ricardo99-42red
Jun 3, 2024Sanchez Obando Alexander Ricardo99-47red
Nov 6, 2023AUSTROFOOD S.A.S.99-42red
Jun 5, 2023Castro Narvaez Natalia Del Lourdes Company16-81red
Jun 5, 2023TIERRA LINDA16-81red
May 10, 2023Gondi S.A.99-38red

Showing the latest 25 of 181.

Most-inspected facilities

FacilityCityInspectionsOAILatest
Franchi Fish S. A.Manta40Aug 1, 2023
Bresson S.AGuayaquil41Nov 20, 2019
Frigolab San Mateo Cia. LtdaJaramigo40Jun 21, 2019
Transmarina C.A.Montecristi40Jun 19, 2019
Pesnusan Cia LtdaManta42Jun 17, 2019
NEGOCIOS INDUSTRIALES REAL S-.A (NIRSA)Guayaquil41Nov 11, 2016
Mardex, S.A.Manta40Nov 10, 2016
Empacadora Bilbo S.A.Montecristi31Jul 28, 2023
Provefrut S.A.Latacunga30Jun 13, 2023
Gondi S.A.Portoviejo31Apr 24, 2023
Pivano S.A.Balzar30Nov 13, 2019
Procesadora Mejia S.A.Guayaquil30Sep 6, 2019
Eurofish S. A.Montecristi30Jun 26, 2019
Ocean Fish, S.A.Manta30Jun 13, 2019
Costapesca, CIA. LTDAQuito30Nov 22, 2016

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.