COLOMBIA
COLOMBIA
FDA import refusal data for products from COLOMBIA
Common Violations
Top Firms
| # | Firm Name | Risk | Refusals |
|---|---|---|---|
| 1 | HERNANDEZ, JOSE ANTONIO Bogota | Risk: 77.8 | 103 |
| 2 | Risk: 66.1 | 78 | |
| 3 | Procaps S.A. Barranquilla | Risk: 76.5 | 60 |
| 4 | SANOFI COLOMBIA Bogota | Risk: 65.7 | 58 |
| 5 | Risk: 55.3 | 57 | |
| 6 | Custom Pet SAS Bogota | Risk: 74.0 | 54 |
| 7 | PRODUCTOS RAMO S.A. Mosquera | Risk: 61.5 | 51 |
| 8 | Colombina, S.A. Zarzal | Risk: 46.4 | 51 |
| 9 | C.I. Agrofrut S.A.S Medellin | Risk: 56.6 | 42 |
| 10 | Risk: 58.8 | 41 | |
| 11 | Osmed Sas Bogota | Risk: 47.2 | 34 |
| 12 | Natural Foods Enterprise SAS Roldanillo | Risk: 60.6 | 33 |
| 13 | Risk: 54.3 | 32 | |
| 14 | Export Andina Ltda Bogota | Risk: 42.6 | 31 |
| 15 | Genfar S A Bogota | Risk: 54.6 | 29 |
| 16 | Cooperativa Colanta Ltda. Medellin | Risk: 57.1 | 28 |
| 17 | Compania Nacional de Chocolates Rionegro | Risk: 70.4 | 25 |
| 18 | Laboratorios Pronabell Ltda Cundinamarca | Risk: 41.1 | 24 |
| 19 | C.I. Pike & Repike Ltda. Medellin | Risk: 47.8 | 24 |
| 20 | PEPSICO COLOMBIA LTDA Bogota | Risk: 46.0 | 23 |
Frequently Asked Questions
How many FDA import refusals are from COLOMBIA?
According to FDA records, there have been 5,615 import refusals for products originating from COLOMBIA, involving 2142 firms.
What products from COLOMBIA are commonly refused by the FDA?
Products from COLOMBIA may be refused for various reasons including adulteration, misbranding, lack of proper registration, or failure to meet U.S. safety standards. The specific products vary by firm and time period. View the common violations section on this page for more details.
Does an import refusal mean products from COLOMBIA are unsafe?
Not necessarily. An import refusal indicates a specific shipment appeared to violate FDA requirements at the time of inspection. Many COLOMBIA firms successfully import products that meet all FDA requirements. Import refusals help identify and prevent non-compliant products from entering the U.S. market.
How current is the FDA import refusal data for COLOMBIA?
Our database includes FDA import refusals for COLOMBIA through 1/22/2026. Data is sourced from the FDA Data Dashboard and updated monthly.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.