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FDA Inspections, Warning Letters and Import Refusals: Chile

FDA has recorded 457 inspections of firms in Chile, 8 of them (1.8%) classified OAI. It has issued 7 warning letters to firms there and refused 1,620 import shipments. 154 firms in Chile 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.

Chile: FDA inspections per year 2017: 39 inspections3920172018: 42 inspections4220182019: 33 inspections3320192020: 12 inspections1220202021: 0 inspections020212022: 13 inspections1320222023: 33 inspections3320232024: 10 inspections1020242025: 14 inspections1420252026: 8 inspections82026
YearInspectionsOAIOAI shareWarning lettersImport refusals
2026800.0%058
20251417.1%072
20241000.0%051
20233300.0%046
20221300.0%041
202100054
20201200.0%055
20193300.0%1260
20184200.0%036
20173900.0%140

Latest OAI inspections

DateFacilityProduct type
Nov 11, 2025Empacadora Lota Seafoods S.A.Food/Cosmetics
May 23, 2014Sociedad Guidomar LtdaFood/Cosmetics
May 6, 2014KyC Seafoods LimitadaFood/Cosmetics
May 10, 2013Alvarez Y Alvarez LtdaFood/Cosmetics
May 7, 2013Comercial Comtesa S.A.Food/Cosmetics
Nov 11, 2011Cermaq Chile S.A. No. 10195Food/Cosmetics
Nov 5, 2011Agropesca S. A.Food/Cosmetics
Sep 16, 2011Alimex S.A.Food/Cosmetics

Latest warning letters

DateFirmProduct typeFDA center
Aug 19, 2019Comercial Mares De Chiloe, SpAFood/CosmeticsCFSAN
Aug 25, 2017Cermaq Chile S.A. No. 10195Food/CosmeticsCFSAN
Nov 24, 2014Sociedad Guidomar LtdaFood/CosmeticsCFSAN
Dec 13, 2013Alvarez Y Alvarez LtdaFood/CosmeticsCFSAN
Dec 13, 2013Comercial Comtesa S.A.Food/CosmeticsCFSAN
Mar 21, 2012Distribucion Y Representaciones Comerciales SAFood/CosmeticsCFSAN
Jan 31, 2012Alimex S.A.Food/CosmeticsCFSAN

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

Latest import refusals

DateFirmProduct category
Oct 6, 2026Laboratorio Chile S.A.Drugs and Biologics
Oct 6, 2026FARMACIAS SOLUFARDrugs and Biologics
Sep 14, 2026Frutas Y Hortalizas Del Sur S.A.Human Foods
Sep 14, 2026Frutas Y Hortalizas Del Sur S.A.Human Foods
Sep 10, 2026PESQUERA LA PORTADA S.AAnimal Feed
Sep 3, 2026Frutas Y Hortalizas Del Sur S.A.Human Foods
Sep 3, 2026Comercial Fruticola S.A.(COMFRUT)Human Foods
Sep 2, 2026Frutas Y Hortalizas Del Sur S.A.Human Foods
Sep 2, 2026Frutas Y Hortalizas Del Sur S.A.Human Foods
Sep 2, 2026Frutas Y Hortalizas Del Sur S.A.Human Foods
Sep 2, 2026Santiago Comercio Exterior Exportaciones S.A.Human Foods
Sep 2, 2026Frutas Y Hortalizas Del Sur S.A.Human Foods
Jul 15, 2026BF COMERCIO Y EXPORTACIONES LTDAHuman Foods
Jul 7, 2026OPKO CHILE S.A.Drugs and Biologics
Jul 7, 2026IPHSA INTERPHARMADrugs and Biologics
Jul 7, 2026Laboratorio Chile S.A.Drugs and Biologics
Jul 7, 2026FAES FARMADrugs and Biologics
Jul 7, 2026Synthon Chile LimitadaDrugs and Biologics
Jul 7, 2026ASCEND LABORATORIES SPADrugs and Biologics
Jul 7, 2026GENOMMA LABDrugs and Biologics
Jul 7, 2026GARDEN HOUSE LABORATORIESDrugs and Biologics
Jul 7, 2026DC DOBLE CAMARADrugs and Biologics
Jul 7, 2026OPKO CHILE S.A.Drugs and Biologics
Jun 17, 2026PESQUERA LA PORTADA S.AAnimal Feed
Jun 16, 2026PESQUERA LA PORTADA S.AAnimal Feed

Showing the latest 25 of 1,620.

Firms on FDA import alerts

PublishedFirmImport alertList
Sep 15, 2026Servicios Porvenir Y Compania SA16-04red
Sep 4, 2026Santiago Comercio Exterior Exportaciones S.A.99-08red
Jul 28, 2026Comercial Fruticola S.A.(COMFRUT)99-35red
Jul 28, 2026Comfrut Curico99-35red
Jul 28, 2026COMFRUT SA99-35red
Jul 27, 2026Frutas Y Hortalizas Del Sur S.A.99-35red
Mar 24, 2026PESQUERA LA PORTADA S.A99-08red
Feb 27, 2026Empacadora Lota Seafoods S.A.16-120red
Oct 2, 2025AGROINDUSTRIAL CAMPOS DEL MAULESPA99-08red
Jul 11, 2025BF COMERCIO Y EXPORTACIONES LTDA99-08red
Apr 4, 2025Sociedad Agroindustrial El Barrancon Ltda.71-04red
Mar 31, 2025Comercial Movimento Ltda71-04red
Dec 27, 2024LVR SOLUCIONES SPA99-08red
Jul 2, 2024AL SUR ALIMENTOS16-39red
Jul 2, 2024Al Sur Alimentos Spa16-39red
Feb 29, 2024Exportadora Prize Limitada99-05red
Feb 29, 2024Prize Proservice S.A.99-05red
Jun 16, 2023Ante Blazevic Borsic99-05red
Apr 3, 2023Exportadora Y Comercial Frigoberries SPA99-08red
Jan 10, 2023Exportadora Copramar Ltda.99-35red
Dec 8, 2022Agrocomercial Quillota99-05red
Mar 28, 2022Exportadora Aconcagua, Ltda99-05red
Mar 28, 2022NAFSA Ltda Exportadora Frutas Naturales De Chile Ltda99-05red
Jan 10, 2022TAAG GENETICS SA89-08red
Nov 16, 2020Agro Industrias Los Almendros De Gultro LTDA99-19red

Showing the latest 25 of 154.

Most-inspected facilities

FacilityCityInspectionsOAILatest
PUREFRUIT CHILE S.ARomeral30Apr 17, 2025
ORIZON S.A.Coronel30Jul 14, 2023
Alimentos Alsan Ltda.Coquimbo30Jan 18, 2023
Pesquera Del Mar Antartico SAPuerto Montt30Jan 14, 2020
Bayas Del Sur S.A.Purranque30May 9, 2019
Patagoniafresh S.A.San Fernando30Apr 1, 2019
Comercial Y Servicios Sur Austral, Ltda.Puerto Montt30Jan 29, 2019
Conservas Y Congelados Puerto Montt, S.A.Puerto Montt30Jan 23, 2019
Cermaq Chile S.A. No. 10195Ancud31Jun 6, 2017
Agricola San Clemente Ltda. Fundo CarenOvalle20Feb 17, 2026
Eduardo Patricio Yanez Ruiz, MDTemuco20Jan 22, 2026
Pacific Nut Company Chile S.A. (P2)San Bernardo20Apr 17, 2024
MAREA DEL SUR GROUP SPAValparaiso20Apr 15, 2024
Servicio De Exportaciones Fruticolas Exser LtdaSan Felipe20Feb 20, 2024
Sea Flavors Sociedad AnonimaPuerto Montt20Apr 11, 2023

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.