FDA Food Facility Registration: A Comprehensive Guide for Manufacturers

Any foreign facility manufacturing, processing, packing, or holding food for US consumption must register with the FDA. This requirement — established under the Bioterrorism Act of 2002 and expanded by FSMA — applies worldwide. Failure to register means food products are legally adulterated and cannot be lawfully imported.

What Is FDA Food Facility Registration?

FDA food facility registration creates an official record with the FDA, assigns an FEI number, and designates a US Agent for foreign facilities. The FDA uses this registry to track the food supply chain, conduct risk-based inspections, and respond to food safety emergencies.

Which Facilities Must Register?

• Food and beverage manufacturers — packaged foods, beverages, condiments, and processed foods

• Dietary supplement manufacturers — vitamins, minerals, botanicals, and functional food products

• Infant formula and pet food manufacturers

• Food ingredient and food additive manufacturers

• Contract food manufacturers producing products for US-branded companies

The Role of the US Agent

Foreign food facilities must designate a US Agent as part of registration. The agent must be US-located, available during US business hours, and receive all FDA communications including inspection notices and import alert notifications. If the FDA cannot reach your agent, your registration may be suspended — causing automatic import holds on all your products.

DUNS Number Requirement

Foreign manufacturers must obtain a DUNS number — a nine-digit identifier from Dun & Bradstreet — before completing FDA food facility registration. The process typically takes three to five business days for international applicants.

How to Register a Food Facility

Step 1: Create an FDA Account

Food facility registration is completed through FDA's FURLS portal. You must first create an FDA Industry Systems account.

Step 2: Complete the Registration Form

The form requires: legal name and address, trade names, facility owner and operator information, type of activities, food product categories, emergency contact, and US Agent details for foreign facilities.

Step 3: Biennial Renewal

FDA food facility registration must be renewed every two years during October 1 through December 31 of even-numbered years. Facilities that don't renew lose registered status and their products are considered adulterated. There is no grace period.

Prior Notice Requirement for Food Imports

In addition to registration, Prior Notice must be filed before every food shipment enters the US — no earlier than 15 days before arrival and no later than two hours before air arrival or four hours before land or sea arrival. Shipments without valid Prior Notice are subject to refusal of admission.

Common FDA Food Facility Registration Mistakes

• Registering the corporate headquarters rather than the manufacturing facility

• Using an incorrect DUNS number — must match the exact legal entity name

• Appointing a US Agent unavailable during US business hours

• Missing the biennial renewal window — no grace period exists

• Failing to update registration when product categories or activities change

How Axentra Helps

Axentra manages FDA food facility registration for foreign manufacturers across all food categories. Services include DUNS acquisition, FDA account setup, facility registration, US Agent designation, and biennial renewal management. Contact us for a free expert assessment.