What Is FDA Food Facility Registration?
Under the Bioterrorism Act of 2002 and reinforced by the FDA Food Safety Modernization Act (FSMA), every domestic and foreign facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States must register with the FDA. This is not optional — it is a federal legal requirement.
Without a valid FDA food facility registration, your shipments can be refused at the U.S. border, resulting in costly detention fees, return shipment expenses, and potential destruction of goods.
Who Needs to Register?
You are required to register if your facility is involved in any of the following activities for food destined for the U.S. market:
- Manufacturing or processing food products
- Packing or re-packing food products
- Holding (storing) food prior to U.S. distribution
- Producing dietary supplements intended for U.S. sale
Notable exemptions include farms, fishing vessels operating as farms, restaurants, retail food establishments, and certain nonprofit food establishments. However, if you are a commercial food exporter, you almost certainly need to register.
What You Need Before You Start
Required Information Checklist
- Full legal name and trade name of the facility
- Complete physical address (no P.O. boxes)
- Emergency contact name and phone number
- U.S. Agent name, address, phone, and email (mandatory for foreign facilities)
- All product categories manufactured/processed/packed/held
- FDA product category codes (from the FDA's official list)
- Approximate annual volume for each product category
- Parent company information (if applicable)
Step-by-Step Registration Process
- 1Designate a U.S. Agent Foreign facilities must designate a U.S.-based agent before submitting. Your U.S. Agent (such as Regovant LLC) will receive all FDA communications on your behalf and must be available 24/7 for emergency contact.
- 2Create an FDA account Register at the FDA's Food Facility Registration portal (Bioterrorism Act Registration). You will need to create an account with a valid email address.
- 3Complete Form FDA 3537 Fill in all required fields including facility details, product categories, and U.S. Agent information. Double-check every address and contact detail — errors are a leading cause of delays.
- 4Submit and receive your FEI number Upon successful submission, the FDA assigns a Food Establishment Identifier (FEI) number. This typically happens within 1–3 business days for electronic submissions.
- 5Receive your Registration Number Your facility receives a 10-digit FDA registration number. This number must be available to U.S. Customs at the time of any food shipment entry.
Common Rejection Reasons to Avoid
Based on our experience processing hundreds of registrations, these are the most frequent reasons FDA registrations are rejected or delayed:
- Incorrect product category codes — Using approximate or incorrect FDA product categories is the #1 mistake. Each product type has a specific code.
- Invalid U.S. Agent information — The U.S. Agent must have a physical U.S. address and be genuinely reachable. P.O. boxes are not accepted.
- Mismatched facility names — The name on the registration must exactly match your official business registration documents.
- Missing emergency contact — The FDA requires a 24/7 emergency contact separate from regular business contacts.
- Submitting too late in the renewal window — Registrations submitted in December during a renewal year may lapse if processing is delayed.
After Registration: What Comes Next
Once registered, your facility is searchable in the FDA's public database. U.S. importers and customs authorities can verify your registration status at any time. You will need to:
- Notify the FDA of any changes to your facility information within 60 days
- Renew your registration every two years (October 1 – December 31 of even-numbered years)
- Comply with FSMA preventive controls requirements if applicable to your product type
- Provide Prior Notice to the FDA before each U.S.-bound shipment
How Regovant Can Help
Regovant LLC acts as your designated U.S. Agent and handles the complete registration process on your behalf — from gathering your facility information to submitting the correct forms and delivering your official Certificate of Registration. Our team has processed registrations for facilities in over 40 countries and maintains a near-perfect approval rate.