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FDA Inspections, Warning Letters and Import Refusals: Peru

FDA has recorded 401 inspections of firms in Peru, 15 of them (3.7%) classified OAI. It has issued 4 warning letters to firms there and refused 2,303 import shipments. 112 firms in Peru 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.

Peru: FDA inspections per year 2017: 34 inspections3420172018: 41 inspections4120182019: 40 inspections4020192020: 0 inspections020202021: 0 inspections020212022: 11 inspections1120222023: 2 inspections220232024: 8 inspections820242025: 13 inspections1320252026: 8 inspections82026
YearInspectionsOAIOAI shareWarning lettersImport refusals
2026800.0%038
20251300.0%055
2024800.0%035
2023200.0%042
20221100.0%057
202100024
202000022
20194037.5%091
20184112.4%092
20173400.0%039

Latest OAI inspections

DateFacilityProduct type
Nov 28, 2019Sociedad Agricola Saturno S.A.Food/Cosmetics
Nov 28, 2019EL PEDREGAL S.A.Food/Cosmetics
Feb 22, 2019Gloria SAFood/Cosmetics
Dec 13, 2018Frozen Products Corporation S.A.C.Food/Cosmetics
Mar 29, 2016Blue Pacifico S.A.C.Food/Cosmetics
Mar 10, 2016PESQUERA NIVAMA SACFood/Cosmetics
Mar 8, 2016PROVEEDORA DE PRODUCTOS MARINOS SACFood/Cosmetics
Sep 19, 2014Procesadora SACFood/Cosmetics
Mar 25, 2014Seven Stars Corporation S.A.C.Food/Cosmetics
Mar 18, 2014Inversiones Prisco S.A.C.Food/Cosmetics
Aug 14, 2012AgrohidroFood/Cosmetics
Feb 19, 2011Perla Del Pacifico, S.R.L.Food/Cosmetics
Jan 28, 2011Inversiones Prisco S.A.C.Food/Cosmetics
Aug 28, 2009GAM CORP S.A.Food/Cosmetics
Aug 24, 2009Nutreina, S.A.Food/Cosmetics

Latest warning letters

DateFirmProduct typeFDA center
Aug 30, 2016PESQUERA NIVAMA SACFood/CosmeticsCFSAN
Aug 23, 2016Blue Pacifico S.A.C.Food/CosmeticsCFSAN
Jul 14, 2014Inversiones Peru Pacifico S.AFood/CosmeticsCFSAN
Jun 15, 2011Inversiones Prisco S.A.C.Food/CosmeticsCFSAN

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

Latest import refusals

DateFirmProduct category
Oct 8, 2026PROCESADORA LARAN SACHuman Foods
Sep 18, 2026COMPANIA AGROINDUSTRIAL SANTA ANHuman Foods
Sep 18, 2026COMPANIA AGROINDUSTRIAL SANTA ANHuman Foods
Sep 18, 2026COMPANIA AGROINDUSTRIAL SANTA ANHuman Foods
Sep 18, 2026PRODUCTOS AGRO ANDINOS SACHuman Foods
Sep 18, 2026PRODUCTOS AGRO ANDINOS SACHuman Foods
Aug 31, 2026SUN PHARMADrugs and Biologics
Jul 27, 2026AGRO E&C S.A.C.Human Foods
Jul 24, 2026PORTUGAL LABORATORYDrugs and Biologics
Jun 30, 2026FUSION FOODS SACHuman Foods
Jun 16, 2026KARINLI INTERNATIONAL FOODS SACHuman Foods
Jun 16, 2026KARINLI INTERNATIONAL FOODS SACHuman Foods
Jun 16, 2026KARINLI INTERNATIONAL FOODS SACHuman Foods
Jun 16, 2026KARINLI INTERNATIONAL FOODS SACHuman Foods
Jun 9, 2026FUSION FOODS SACHuman Foods
Jun 9, 2026FUSION FOODS SACHuman Foods
Jun 3, 2026FUSION FOODS SACHuman Foods
Jun 3, 2026FUSION FOODS SACHuman Foods
May 5, 2026KARINLI INTERNATIONAL FOODS SACHuman Foods
May 5, 2026KARINLI INTERNATIONAL FOODS SACHuman Foods
May 5, 2026KARINLI INTERNATIONAL FOODS SACHuman Foods
May 5, 2026KARINLI INTERNATIONAL FOODS SACHuman Foods
May 5, 2026KARINLI INTERNATIONAL FOODS SACHuman Foods
Apr 27, 2026WORLD PANTRY SACHuman Foods
Apr 27, 2026WORLD PANTRY SACHuman Foods

Showing the latest 25 of 2,303.

Firms on FDA import alerts

PublishedFirmImport alertList
Sep 23, 2026COMPANIA AGROINDUSTRIAL SANTA AN99-08red
Sep 23, 2026PRODUCTOS AGRO ANDINOS SAC99-08red
Apr 1, 2026KARINLI INTERNATIONAL FOODS SAC99-08red
Jan 16, 2026FAIR FRUIT PERU SAC99-05red
Oct 2, 2025FATISHA EXPORT S.A.C.99-05red
Aug 26, 2025Ecoandino S.A.C.99-42red
May 20, 2025Ceramica Peru S.A.99-45red
Apr 4, 2025Serramon S.A.71-04red
Apr 3, 2025RABC INTERGAME Eirl71-04red
Apr 1, 2025Exportaciones E Importaciones Natur71-04red
Mar 26, 2025ANDEAN GROWERS GROUP S.A.C99-05red
Feb 13, 2025FUSION FOODS SAC99-08red
Oct 24, 2024EXPORTACIONES LAND PERU SAC.99-32red
Oct 7, 2024FUSION FOODS SAC99-08red
Jun 28, 2024AGRICOLA DACC EIRL99-05red
Jun 25, 2024JALEB CORPORATION GROUP E.I.R.L.99-05red
Sep 29, 2023TA EXPORT S.A.C.99-05red
May 22, 2023MEGABUSINESS PERU S.A.C.99-08red
May 19, 2023Fito Peru Export Import S.A.C.66-41red
Dec 16, 2022JM ASOCIADOS SUMA SAC99-05red
Jun 6, 2022INTERLOOM SAC99-08red
Apr 1, 2022Alimentos Los Ferroles S.A.C.16-105red
Apr 1, 2022DEEPER BLUE SEA LLC, SUCURSAL PERU16-105red
Apr 1, 2022Perla Del Pacifico, S.R.L.16-105red
Nov 8, 2021Consorcio Grupo Empresarial Fukuda99-05red

Showing the latest 25 of 112.

Most-inspected facilities

FacilityCityInspectionsOAILatest
SEAFROST S.A.C.Piura50Feb 28, 2019
CAMPOSOL S.A.Viru40Oct 14, 2022
Inversiones Prisco S.A.C.Piura42Mar 18, 2016
Green Vegetables & Flowers S.A.C.Santa Rosa De Quives30Mar 26, 2024
Sociedad Agricola Saturno S.A.Morropon31Jan 11, 2023
Gloria SALima31Jun 23, 2022
Agroindustrias AIBChincha30Mar 26, 2019
Intipa Foods S. A. C.Caraz30May 20, 2016
IQF Del Peru S.A. (Ica Factory)Ica30Feb 23, 2016
Agricola Los Medanos S.A.Ica20Mar 27, 2026
AGRICOLA MIRANDA S.A.C.Salas20Aug 12, 2025
Fito Peru Export Import SACPachacamac20Apr 4, 2025
Unilene SacLima20Sep 26, 2024
Agroindustrias Osho S.A.C.Callao20Nov 12, 2022
Procesadora SACChiclayo21Jul 1, 2022

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.