FDA Food Facility Registration Step by Step: A Process Guide for Foreign Manufacturers

FDA food facility registration is a process with a fixed sequence. Foreign manufacturers who start in the middle — by going directly to the FDA's FURLS system before completing the prerequisites — encounter problems that delay the registration by weeks and sometimes require starting over. Understanding the correct order of operations before beginning is the most direct way to complete the registration without unnecessary delays.

Step 1: Determine if your facility must register

Not every facility that produces food must register with the FDA. Farms that grow and harvest raw agricultural commodities, restaurants, and retail food establishments are generally exempt from the food facility registration requirement. Foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States must register, with very limited exceptions. If the product being manufactured is regulated as a food under the Federal Food, Drug, and Cosmetic Act — which includes conventional foods, beverages, dietary supplements, and infant formula — and it is exported to the United States, the manufacturing facility must be registered before any shipment is made.

Step 2: Obtain a DUNS number before filing

The FDA requires a DUNS number as the Unique Facility Identifier in food facility registration submissions. The DUNS number must be obtained before the FDA filing is started. Apply directly with Dun & Bradstreet at their website. The DUNS application requires the facility's legal business name, physical address, primary contact, and main business activity. The name and address in the DUNS record must match the name and address that will be used on the FDA registration form exactly — character for character, including abbreviations and address format. Allow five to ten business days for standard DUNS processing. If you need the number faster, D&B offers an expedited option.

Step 3: Designate a US Agent before the FDA filing

Every foreign food facility must designate a US Agent at the time of FDA registration. The US Agent must be physically located in the United States, reachable by the FDA at all times, and willing to accept the designation in writing before the registration is submitted. The US Agent is not the same as a US importer or a US distributor — it is a specific regulatory role. Many foreign manufacturers use a regulatory services firm as their US Agent rather than a US business partner, because the regulatory services firm has the systems and expertise to respond to FDA communications reliably. The US Agent's name, address, phone number, and email must be included in the FDA registration filing.

Step 4: Complete the FDA filing in FURLS

The FDA's food facility registration is submitted through the FURLS system — the FDA Unified Registration and Listing System. The registrant creates an account in FURLS, selects the food facility registration module, and completes the registration form with the facility name, physical address, DUNS number, US Agent information, and the food product categories manufactured at the facility using the FDA's product category codes. When the registration is submitted and accepted, the FDA issues a FEI number — the FDA Establishment Identifier — that confirms the facility is registered. The FEI number should be retained; it is used in Prior Notice submissions and in FDA database lookups for every subsequent shipment to the United States.

Step 5: Maintain the registration continuously

A food facility registration must be renewed periodically to remain active. Between renewals, any change in the registered information — facility name, address, US Agent, product categories — must be updated in FURLS within 60 days of the change. A registration that contains outdated information is technically non-compliant even if it has not yet lapsed, and the FDA has authority to act on inaccurate registrations. Prior Notice submissions that list a facility whose registration does not match the current FDA record can generate holds on incoming shipments.

How FDABridge manages the full registration process

FDABridge handles every step of FDA food facility registration for foreign manufacturers — DUNS acquisition, US Agent appointment, FURLS filing, FEI confirmation, and ongoing registration maintenance. We track renewal deadlines and registration status continuously. Visit fdabridge.com/food to learn about our food registration services or fdabridge.com/apply/food to start the process.