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FDA Inspections, Warning Letters and Import Refusals: Colombia

FDA has recorded 102 inspections of firms in Colombia, 2 of them (2.0%) classified OAI. It has issued 4 warning letters to firms there and refused 5,796 import shipments. 94 firms in Colombia 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.

Colombia: FDA inspections per year 2017: 1 inspections120172018: 30 inspections3020182019: 29 inspections2920192020: 1 inspections120202021: 0 inspections020212022: 0 inspections020222023: 1 inspections120232024: 1 inspections120242025: 0 inspections020252026: 0 inspections02026
YearInspectionsOAIOAI shareWarning lettersImport refusals
2026000214
2025000304
2024100.0%1293
2023100.0%0199
2022000198
2021001344
2020100.0%0593
20192900.0%0375
20183013.3%0804
2017100.0%0298

Latest OAI inspections

DateFacilityProduct type
Jun 8, 2018Laboratorios Baxter S.A.Drugs
Aug 10, 2009Grupo Alimentario Del Atlantico S.A.Food/Cosmetics

Latest warning letters

DateFirmProduct typeFDA center
Jan 9, 2024COMERCIALIZADORA INTERNACIONAL C I PISCICOLA NEWYORK S A RIVERAFood/CosmeticsCFSAN
Apr 5, 2021Proquimes S A Productos Quimicos Especializados S ADrugsCDER
May 15, 2012C.I. Farmacapsulas S.A.DrugsCDER
Dec 23, 2009Grupo Alimentario Del Atlantico S.A.Food/CosmeticsCFSAN

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

Latest import refusals

DateFirmProduct category
Oct 21, 2026ALMENAT SASHuman Foods
Oct 19, 2026ALMENAT SASHuman Foods
Oct 14, 2026Caninos Plus S.A.SAnimal Feed
Oct 9, 2026FRANCO COLOMBIAN LABORATORYDrugs and Biologics
Oct 9, 2026C.I Farmacapsulas S.ADrugs and Biologics
Oct 9, 2026JORGE LAMBISDrugs and Biologics
Oct 8, 2026ALMENAT SASDrugs and Biologics
Oct 6, 2026CINDY JULIANA SANTOS AZADrugs and Biologics
Sep 30, 2026GENFAR DESARROLLODrugs and Biologics
Sep 25, 2026LABORATORIOS PRANA SASDrugs and Biologics
Sep 25, 2026Procaps S.A.Drugs and Biologics
Sep 25, 2026ELABORADO POR COASPHARMA SASDrugs and Biologics
Sep 25, 2026SyntofarmaDrugs and Biologics
Sep 25, 2026LABORATORIES ECAR SADrugs and Biologics
Sep 25, 2026UNKNOWNDrugs and Biologics
Sep 25, 2026Laboratorio Franco Colombiano Lafrancol S.A.Drugs and Biologics
Sep 25, 2026LabincoDrugs and Biologics
Sep 25, 2026Pharmayect S.A.Drugs and Biologics
Sep 25, 2026Pharmayect S.A.Drugs and Biologics
Sep 25, 2026Laboratorios Laproff S.A.Drugs and Biologics
Sep 25, 2026Fareva Villa Rica S.A.SDrugs and Biologics
Sep 25, 2026ANGLOPHARMA S.A.Drugs and Biologics
Sep 17, 2026AGRICOLA HIMALA SAHuman Foods
Sep 17, 2026AGRICOLA HIMALA SAHuman Foods
Sep 17, 2026AGRICOLA HIMALA SAHuman Foods

Showing the latest 25 of 5,796.

Firms on FDA import alerts

PublishedFirmImport alertList
Jul 9, 2026ALMENAT SAS54-16red
May 29, 2026COMERCIALIZADORA INTERNACIONAL C I PISCICOLA NEWYORK S A RIVERA16-125green
May 29, 2026SALA DE EVISCERADO Y FILETEADO S.A.16-125green
Jan 22, 2026C.I. AGROFRUT S.A.S99-08red
Dec 1, 2025KOMENT SAS89-08red
Aug 4, 2025PET DIRECT S A S71-04red
Jul 30, 2025THE CLICK LIFESTYLE SAS68-19red
May 8, 2025MANDARINOS ASO SAS99-05red
Apr 8, 2025Rosdel S.A.S.99-05red
Apr 3, 2025LAS VAQUITAS71-04red
Apr 3, 2025PET TREATS FACTORY LTDA71-04red
Apr 3, 2025Pet Treats Factory S.A.S.71-04red
Apr 2, 2025Inverplanet71-04red
Apr 1, 2025Custom Pet SAS71-04red
Mar 31, 2025AMCF Flavory71-04red
Mar 31, 2025Caninos Plus S.A.S71-04red
Oct 29, 2024LABORATORIOS ERMA S.A.68-20red
Aug 15, 2024HDH GROUP S A S99-05red
Mar 28, 2024LA SUERTE99-05red
Mar 22, 2024Jc Correa Sas66-41red
Feb 27, 2024Compania Nacional De Chocolates99-42red
Jan 16, 2024COMERCIALIZADORA MAXI FINCA SAS99-05red
Apr 28, 2023MEDALLA99-05red
Apr 28, 2023SAN JAVIER99-05red
Apr 26, 2023GRAN VIA99-05red

Showing the latest 25 of 94.

Most-inspected facilities

FacilityCityInspectionsOAILatest
Procaps S.A.Barranquilla50Apr 28, 2023
Grupo Alimentario Del Atlantico S.A.Barranquilla31Apr 2, 2019
Compania Envasadora Del Atlantico S.A.S.Barranquilla30Mar 27, 2019
Bel Star S.A.Tocancipa20Dec 13, 2019
Humberto Reynales, MD, PhDBogota20Oct 30, 2019
C.I. Antillana S.A.Cartagena20Apr 16, 2019
Pesquera Larosa Del Mar S.A.Barranquilla20Mar 29, 2019
Productos Rimar LtdaBogota20May 28, 2018
C.I. AGROFRUT S.A.SLa Estrella20May 16, 2018
Alpina Productos Alimenticios S.A.Facatativa20Apr 27, 2018
Jose Fernando Molina Restrepo, M.D.Medellin20Dec 8, 2017
Dr. Jorge Antonio Piedrahita Olier, MDBarranquilla10Dec 5, 2024
Victor Sierra, M.D.Yopal10Feb 28, 2020
Hada International SASBarranquilla10Dec 12, 2019
Laboratorios Rety De Colombia SASBarranquilla10Dec 6, 2019

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.