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FDA facility registration

Any foreign facility that manufactures, processes, packs or holds food for consumption in the United States has to be registered with the FDA, with a US agent named. It renews on a cycle, and lapsed registration refuses food as reliably as no registration at all.

The essentials.

The facility registers, not the exporter
Registration attaches to the premises where the food is made, processed, packed or held. A trader cannot register on a producer's behalf.1
A United States agent is required
Foreign facilities name a US agent for communications, and the agent has to confirm the appointment.
It expires
Registration is renewed on a biennial cycle. A lapse is invisible until a shipment is refused, and it happens.
It is separate from FSVP and prior notice
Three different obligations on different parties. Registration is the producer's, FSVP and prior notice are the importer's.1

Who asks for it.

Only these markets require it. Shipping the same goods anywhere else, the question does not arise.

What it does not cover.

  • It is not an approval of the food

    Registration means the facility told the FDA it exists and what it does. Nobody inspected anything. Buyers read it as a quality signal and it is an administrative one.

  • It does not cover your own obligations

    A registered supplier does nothing for your foreign supplier verification programme, which examines how you verified them rather than whether they filed a form.

  • Lapses are the common failure

    The producer registered once, the renewal cycle passed, and nobody noticed until a container was refused. Ask for the registration and the renewal date rather than the number alone.

Questions buyers ask.

Can I register the factory myself?

No. The facility registers, and it names a United States agent for communications. What a buyer can do is confirm the registration is current before ordering, which is a check almost nobody performs.

Does registration mean the FDA inspected them?

No. It is a notification that the facility exists and what it handles. FDA does inspect foreign facilities and registration is not that inspection, and buyers routinely read one as the other.

What if it lapsed?

The food is refused at entry, and the fix takes time you do not have with a container at a port. Ask for the renewal date as well as the number.

Sources

  1. 1Foreign Supplier Verification Programs for importers of food. US Food and Drug Administration. Checked 5 August 2026.

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