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.

⚠️ Important: Registration must be renewed every two years during the October–December window. Lapsed registrations can cause immediate shipment refusals even for long-standing exporters.

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:

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

  1. 1
    Designate 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.
  2. 2
    Create 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.
  3. 3
    Complete 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.
  4. 4
    Submit 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.
  5. 5
    Receive 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:

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:

✅ Pro tip: Keep a copy of your registration confirmation and FEI number on file. U.S. importers and retailers will frequently ask for these when establishing business relationships.

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.

✅ Need help with this? Regovant handles the entire FDA registration process for you. View our services →