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FDA Food Facility Registration for Colombian Companies

Exporting coffee, cacao, fruit, panela and snacks from Colombia to the U.S.? Each facility that makes, packs or stores them must be registered with the U.S. FDA and name a U.S. Agent, in addition to your INVIMA and ICA approvals. We do it for $269 a year.

  • Registration filed in 1 to 5 business days once we have your details
  • U.S. Agent service in the United States included
  • Certificate of registration your U.S. buyers can verify online
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Pricing for Colombian companies

USD
Registration + U.S. AgentPer facility, per year$269
Additional facilitySame owner$169
Prior NoticePer shipment$25
FDA charges no fee for food registrationCard or PayPal

Do Colombian food companies need FDA registration?

Yes. Under U.S. law, every facility that manufactures, processes, packs or holds food for people or animals in the United States must be registered with the U.S. Food and Drug Administration. This applies to facilities in Colombia exactly as it does to U.S. facilities. Typical Colombian products we register include coffee, cacao and chocolate, bananas, avocados, panela and snacks.

Your INVIMA and ICA approvals are still needed at home, but they do not replace FDA registration. Without a valid FDA registration, your shipments can be held at the U.S. port and your importer cannot file Prior Notice correctly.

What you need

  • The facility's legal name and exact physical address
  • A D-U-N-S number for that address. It is free from Dun & Bradstreet but can take several weeks, so request it early.
  • An emergency contact phone answered 24 hours a day
  • A list of the foods made, packed or stored at the facility

Fresh fruit and vegetables

Fresh produce may also need U.S. Department of Agriculture (USDA) import permits. A farm that only grows and harvests its own crops is generally exempt from FDA facility registration, but a packing house usually must register. We check which of your sites need it.

Labels in English

All information FDA requires must appear in English on products sold in the U.S. A label only in Spanish is not enough, and the U.S. Nutrition Facts format is different. See our label reviews.

How Regovant helps

  1. Order online and pay by card or PayPal in U.S. dollars. $269 per facility per year.
  2. Send your details through one short registration form.
  3. We check and file. We check your D-U-N-S details, file with FDA and act as your U.S. Agent.
  4. You receive your FDA registration number and a Regovant certificate of registration your buyers can verify.

Food facility registrations are renewed between October 1 and December 31 of every even-numbered year. We email you before each renewal. See the 2026 renewal guide or our step-by-step registration guide.

Questions

We are approved by INVIMA. Do we still need FDA registration?

Yes. Approvals at home cover Colombia. For the U.S., each facility that makes, packs or stores the food must be registered with the U.S. FDA.

Do Colombian facilities need a U.S. Agent?

Yes. Every food facility outside the U.S. must name a U.S. Agent located in the United States. It is included in our $269 price.

Can you register more than one of our facilities?

Yes. Each address is registered separately. Additional facilities with the same owner are $169 each.

Registering from another country? See FDA registration by country.