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FDA Inspections, Warning Letters and Import Refusals: Guatemala

FDA has recorded 197 inspections of firms in Guatemala, 4 of them (2.0%) classified OAI. It has issued 4 warning letters to firms there and refused 3,999 import shipments. 84 firms in Guatemala 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.

Guatemala: FDA inspections per year 2017: 41 inspections4120172018: 23 inspections2320182019: 3 inspections320192020: 0 inspections020202021: 0 inspections020212022: 0 inspections020222023: 0 inspections020232024: 0 inspections020242025: 0 inspections020252026: 9 inspections92026
YearInspectionsOAIOAI shareWarning lettersImport refusals
2026900.0%0735
2025000461
2024000386
2023000137
2022000140
202100199
2020000134
2019300.0%075
20182300.0%0108
20174100.0%0126

Latest OAI inspections

DateFacilityProduct type
Feb 12, 2013Productos Alimenticios Centroamericanos, S.A.Food/Cosmetics
Dec 13, 2012Asociacion De Pequenos Agricultores Comalapenses De ProductoFood/Cosmetics
Oct 29, 2010Conservas Y Congelados YAESTA, S.A.Food/Cosmetics
May 27, 2009Industria Tiburonera Inmensa MarFood/Cosmetics

Latest warning letters

DateFirmProduct typeFDA center
Dec 29, 2021Genesis Partnership Company SADrugsCDER
Jul 1, 2013Productos Alimenticios Centroamericanos, S.A.Food/CosmeticsCFSAN
Mar 26, 2013Asociacion De Pequenos Agricultores Comalapenses De ProductoFood/CosmeticsCFSAN
Feb 17, 2011Conservas Y Congelados YAESTA, S.A.Food/CosmeticsCFSAN

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

Latest import refusals

DateFirmProduct category
Oct 22, 2026LAB LAFAGEHuman Foods
Oct 21, 2026SELECTPHAMADrugs and Biologics
Oct 21, 2026MERCK S ADrugs and Biologics
Oct 21, 2026LUMINOVA PHARMA GROUPDrugs and Biologics
Oct 21, 2026InfasaDrugs and Biologics
Oct 21, 2026BAYER DE GUATEMALADrugs and Biologics
Oct 21, 2026LUMINOVA PHARMA GROUPDrugs and Biologics
Oct 21, 2026SELECTPHAMADrugs and Biologics
Oct 15, 2026Alimentos Maravilla S.A.Human Foods
Oct 15, 2026Alimentos Maravilla S.A.Human Foods
Oct 15, 2026Alimentos Maravilla S.A.Human Foods
Oct 15, 2026Alimentos, S.A.Human Foods
Oct 15, 2026ALIMENTOS RENE Y CIA S AHuman Foods
Oct 15, 2026ALIMENTOS RENE Y CIA S AHuman Foods
Oct 15, 2026ALIMENTOS RENE Y CIA S AHuman Foods
Oct 15, 2026ALIMENTOS RENE Y CIA S AHuman Foods
Oct 15, 2026ALIMENTOS RENE Y CIA S AHuman Foods
Oct 15, 2026ALIMENTOS RENE Y CIA S AHuman Foods
Oct 15, 2026ALIMENTOS RENE Y CIA S AHuman Foods
Oct 15, 2026ALIMENTOS RENE Y CIA S AHuman Foods
Oct 15, 2026ALIMENTOS RENE Y CIA S AHuman Foods
Oct 15, 2026ALIMENTOS RENE Y CIA S AHuman Foods
Oct 15, 2026CORPORACION DE INSTANTANEOS SAN ISABEL, SOCIEDAD ANONIMAHuman Foods
Oct 15, 2026CORPORACION DE INSTANTANEOS SAN ISABEL, SOCIEDAD ANONIMAHuman Foods
Oct 15, 2026CORPORACION DE INSTANTANEOS SAN ISABEL, SOCIEDAD ANONIMAHuman Foods

Showing the latest 25 of 3,999.

Firms on FDA import alerts

PublishedFirmImport alertList
Apr 24, 2026Fresh Foods AM99-05red
Jan 14, 2026Agroexportadora El Rejon, S.A.99-05red
May 16, 2025Special Fruit & Vegetable Export, S.A.99-05red
Apr 21, 2025Alimentos Rayo De Luz, S.A.99-08red
Feb 13, 2025AGRO EXPORTADORA VERDE Y FRESCO99-05red
Feb 7, 2025Natura Mix99-08red
Dec 20, 2024AGROEXPORTADORA BALAMYA, S.A.99-05red
Dec 9, 2024Nostalgia Foods S.A.99-39red
Sep 26, 2024Alimentos Maravilla S.A.45-02red
Sep 12, 2024DP INVERSIONES, S.A.99-05red
Sep 6, 2024Cooperativa Agricola Integral Union De Cuatro Pinos R.L.99-05red
Aug 21, 2024Alnost Guatemala S.A99-39red
Mar 26, 2024Vegetales Y Frutas De Calidad CA, Sociedad Anonima99-05red
Nov 2, 2023Alimentos Maravilla S.A.99-39red
Oct 31, 2023Industria Cosmetica Kent SA66-40red
Aug 31, 2023LAS DELICIAS DE GUATEMALA S.A.45-02red
Apr 25, 2023Agricola Tierra Nueva S.A.99-05red
Apr 3, 2023PROSESAMO, S.A.99-08red
Oct 14, 2022Hispanic Foods S.A.99-42red
May 3, 2022Planta BNC - Alimentos Ideal Manufacturing45-02red
Jan 26, 2022Agro Export Valle Del Sol99-05red
Apr 20, 2021Exportadora Catalunia16-74red
Sep 9, 2020ALIFREX SA99-35red
Sep 2, 2020Genesis Partnership Company SA66-78red
Apr 3, 2020Agroinpac99-05red

Showing the latest 25 of 84.

Most-inspected facilities

FacilityCityInspectionsOAILatest
Ayco Farms Guatemala, S. A.Teculutan30May 29, 2026
High Q International S.A. - Quebrada HondaEstanzuela30Jun 15, 2017
Agro Export Valle Del SolSumpango30Apr 21, 2017
High Q International S.A. - Planta Central (SOL Central)Zacapa20May 22, 2026
High Q International, S.A. - Planta Estanzuela (SOL Planta Estanzuela)Estanzuela20May 22, 2026
Exportadora De Frutas Y Vegetales Congeladas Y Envasadas S.AAmatitlan20Aug 27, 2019
EMBOTELLADORA LA MARIPOSA S.A.Guatemala20Aug 22, 2019
TROPILIGHT S.A.Escuintla20Aug 31, 2018
Total Fresh S.A.Santa Lucia Milpas Altas20Feb 14, 2018
Special Fruit & Vegetable Export, S.A.Guatemala20Feb 13, 2018
PRODUCTOS ALIMENTICIOS YAESTA, SOCIEDAD ANONIMAMixco20Feb 13, 2018
Alimentos Sumar, S.A.El Tejar20Jan 15, 2018
Productos Alimenticios Centroamericanos, S.A.San Miguel Petapa21Jul 20, 2017
Semillas Universales SASan Sabastian20Jul 14, 2017
NESTLE GUATEMALA,S.A. ANTIGUA'S FACTORYAntigua Guatemala20Jun 28, 2017

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.