What is FDA food facility registration?
Under the Bioterrorism Act of 2002, as updated by the Food Safety Modernization Act (FSMA), any facility in the U.S. or abroad that manufactures, processes, packs or holds food for people or animals in the United States must register with FDA. The rules are in 21 CFR Part 1, Subpart H.
Food imported from an unregistered facility can be held at the U.S. port of entry. That means storage costs, delays and possible refusal of the shipment.
Who needs to register?
You need to register if your facility does any of these for food sold in the U.S.:
- Manufactures or processes food
- Packs or repacks food
- Labels or relabels food
- Holds (stores) food before it reaches the U.S.
- Makes dietary supplements for U.S. sale
Farms, restaurants, retail food establishments, certain nonprofit food establishments and fishing vessels that don't process their catch are generally exempt. A foreign facility only needs to register if its food is shipped to the U.S. without further manufacturing or processing by another foreign facility, beyond minor steps such as labeling.
What you need before you start
- The facility's full legal name and any trade names
- The facility's physical street address (no P.O. boxes)
- A D-U-N-S number for that exact address. FDA uses it as the Unique Facility Identifier and will not issue a registration number until it can verify it.
- Owner, operator or agent in charge, with contact details
- An emergency contact phone number
- A U.S. Agent with a U.S. address, phone and email (required for foreign facilities)
- The facility's activities and the FDA food product categories it handles
- Parent company details, if any
Step-by-step registration process
- Get or check your D-U-N-S number. The name and address in your D-U-N-S record must match your registration exactly. A new number for a non-U.S. company can take up to 30 business days, so start early. See how to get a D-U-N-S number.
- Appoint a U.S. Agent. FDA emails the U.S. Agent to confirm they agreed to act for your facility. If they don't confirm, FDA can cancel the registration. Regovant LLC acts as U.S. Agent for its registration clients.
- File the registration (Form FDA 3537). The filing is made online through FDA's Food Facility Registration Module, with your facility details, product categories and U.S. Agent information.
- FDA verifies the details. FDA checks the D-U-N-S number against your name and address and waits for the U.S. Agent's confirmation.
- Receive your registration number. FDA issues an 11-digit food facility registration number. Your importer or customs broker uses it for Prior Notice on each shipment.
Common reasons registrations are delayed or cancelled
- D-U-N-S mismatch. The name or address in the D-U-N-S record doesn't match the registration. FDA cancels registrations with an unacceptable D-U-N-S number.
- Wrong product categories. Each food type has its own FDA category. Guessing leads to errors and problems at the port.
- U.S. Agent didn't confirm. The agent must answer FDA's verification request.
- Mismatched facility names. Use the name on your official business registration.
- Leaving renewal to the last days of December. If anything needs fixing, there may not be time before the deadline.
After registration
- Update FDA within 60 days of any change to the required information, such as a new address or U.S. Agent.
- Renew between October 1 and December 31 of every even-numbered year.
- Make sure Prior Notice is filed before each shipment arrives.
- Follow FSMA rules that apply to your products, such as preventive controls, and make sure your U.S. importer has an FSVP if one is required.
FDA does not publish food facility registrations. Keep your registration number and confirmation on file: importers and buyers will ask for them.
How Regovant can help
Regovant LLC files your registration, checks your D-U-N-S details, acts as your U.S. Agent and sends you a certificate of registration you can verify online. Registration with U.S. Agent service is $269 per year.