If your supplier manufactures, processes, packs or holds food that will be eaten in the US, its facility must be registered with the US Food and Drug Administration (FDA). Without a valid registration, the shipment can be refused at the US border.
Registration is a listing, not an approval. A registration number does not mean the FDA has inspected or endorsed the plant. It only means the FDA knows the plant exists and how to reach it, so you still need your own checks on how the plant works.
How registration works
The requirement comes from the Bioterrorism Act of 2002 and was strengthened by the Food Safety Modernization Act (FSMA). The facility registers online with the FDA and receives a registration number.
- Who registers: the facility that makes, processes, packs or holds the food. A trading office with no plant may not be the right registrant.
- US agent: a foreign facility must name a US agent who can be contacted by the FDA.
- Renewal: registrations must be renewed every two years, in a window at the end of each even-numbered year. Lapsed registrations are removed.
- Inspection consent: the facility agrees that the FDA may inspect it.
- Unique facility identifier: the FDA now asks for one, and accepts a DUNS number.
Extra rules for some foods
Canned and bottled foods may need more. Low-acid canned foods and acidified foods require a separate food canning establishment registration and a process filing for each product and container size. Whether a product such as canned pulp or a pickle falls into these groups depends on its pH and how it is made. Check with the FDA or a US regulatory adviser before you order.
Every shipment also needs prior notice to the FDA before it arrives. This is usually filed by the importer or customs broker, not the factory.
How to check your supplier
The FDA does not publish a public list of registered facilities, so you rely on the supplier's documents and your own checks. Your own duties as importer are covered in the FSVP rule for US importers.
- Ask for the registration number and the address registered against it.
- Confirm the address is the plant that makes your product, not a sales office.
- Ask who the US agent is and when the registration was last renewed.
- Confirm any canning registration and process filings if the product is canned or acidified.
- Ask whether the plant has had an FDA inspection, and the outcome.
- Check whether the plant or product appears on an FDA import alert.
Where we come in
We confirm each shortlisted plant's FDA registration details, canning filings where relevant and import alert history before you order. We also gather the supplier records your FSVP file needs. Start with a free sourcing review.