If your company manufactures, processes, packs, or holds food intended for U.S. consumers, FDA food facility registration is not optional. Under the Food Safety Modernization Act (FSMA), food from unregistered foreign facilities can be held at the U.S. port of entry, a costly disruption no importer wants to face.
Here’s exactly what you need to do.
Step 1: Confirm You’re Required to Register
Foreign facilities must register with the FDA if they manufacture, process, pack, or hold food for U.S. consumption. This includes:
- Human food and beverages
- Dietary supplements
- Animal food and feed
- Infant formula
A few categories are exempt, including farms, restaurants, retail food establishments, and nonprofit food establishments. But most foreign food manufacturers shipping to the U.S. are required to register.
Step 2: Appoint a U.S. Agent
This is where many foreign companies face challenges. The FDA requires every foreign food facility to designate a U.S. Agent: a person or company physically located in the United States who can act as your point of contact with the FDA.
Your U.S. Agent must be reachable and able to receive FDA communications on your behalf, including inspection notices and import alerts. You are required to provide an emergency contact number for your agent. Listing a U.S. contact who doesn’t actually understand FDA processes is a compliance risk.
Step 3: Gather Your Registration Information
Before logging into the FDA’s system, have the following ready:
- Legal name and physical address of the facility
- Name and contact information of the facility owner or operator
- All food categories produced at the facility (FDA uses a specific code list)
- Your U.S. Agent’s name, address, and contact information
- Emergency contact information
Step 4: Create an FDA Account and Register via the FDA Industry Systems Portal
The FDA’s Food Facility Registration is submitted through the FDA Industry Systems (FIS) portal at https://www.access.fda.gov. Create an account if you don’t already have one.
Once logged in, complete the online registration form carefully. For foreign facilities, your designated U.S. Agent must confirm the registration before the FDA will finalize it and issue your registration number. Errors or incomplete information can delay that process or trigger compliance issues.
Upon successful submission and U.S. Agent confirmation, the FDA will assign your facility a registration number. You will need this number for FDA Prior Notice submissions when importing food into the U.S.
Step 5: Renew Every Two Years
FDA food facility registration must be renewed every even-numbered year between October 1 and December 31. If you miss the window, your registration expires and is removed from your account, meaning your shipments can be refused at the U.S. border.
Mark it on your calendar. Set a reminder. Better yet, work with someone who tracks it for you.
Step 6: Update Your Registration When Anything Changes
If your facility changes its name, address, ownership, food categories, or U.S. Agent, you must update your FDA registration promptly. FDA regulations specify a 60-day window for certain changes, including ownership transfers and facility closures. Treat any material change as time-sensitive.
Common Pitfalls to Avoid
- Using an unresponsive U.S. Agent. The FDA requires U.S. Agent confirmation before issuing your registration number. An agent who is slow or unreachable can delay or jeopardize your registration entirely.
- Missing the biennial renewal window. The October through December window is firm. An expired registration requires a fresh submission, and your imports can be held in the meantime.
- Incorrect food product categories. The FDA’s classification codes are specific. Listing the wrong categories can trigger import holds.
- Assuming one registration covers multiple facilities. Each physical location requires its own registration.
Let Us Handle It for You
FDA registration is straightforward once you’ve done it a few times. But if this is your first time entering the U.S. market, or if your previous U.S. Agent has been slow or unresponsive, the process is easy to get wrong.
FDAEntry.com specializes in exactly this. We serve as your U.S. Agent, manage your FDA registration from start to finish, handle biennial renewals, and make sure you’re never caught off guard by an FDA communication. Our team knows FDA requirements inside and out, and we work with foreign manufacturers across food, supplements, medical devices, and more.
If you’re ready to get registered or want to make sure your existing registration is in good standing, contact us and we’ll take it from there.