A domestic or foreign facility that manufactures, processes, packs or holds food for human or animal consumption in the United States generally must register with FDA unless an exemption applies. Decide by the actual site, activity and product; being an exporter alone does not establish a facility-registration duty.
Check the facility and exemptions
21 CFR 1.226 contains exemptions for certain farms, restaurants, retail food establishments and other defined activities. A trading company that does not operate a covered facility does not register solely because it sells food. A separate physical manufacturing or holding site may need its own registration. Assess complex farm or mixed activities against the actual definitions rather than applying a blanket rule.
Keep identifiers and roles separate
FDA currently accepts a facility-specific DUNS number as the food unique facility identifier (UFI). D&B controls issuance and record correction; FDA says the first four DUNS numbers can be obtained free and a new number may take up to 45 days. FEI is a different identifier, and neither FEI nor DUNS is the FDA food registration number. A covered foreign facility names a U.S. Agent for FDA contact; the Agent is not automatically the FSVP importer.
Submit and retain completion evidence
An authorized person uses FDA Industry Systems/FURLS to submit or update the record and confirms any U.S. Agent acceptance and FDA outcome. Keep the final registration number and status. Prior Notice, when required, is a separate shipment task. FDA charges no food facility registration or renewal fee; optional FDABridge professional service prices depend on the chosen scope. Registration does not approve a food or guarantee admission.
For the service and pricing choices, see https://fdabridge.com/food-facility-registration and https://fdabridge.com/pricing . FDA guidance: https://www.fda.gov/food/online-registration-food-facilities and https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-H/section-1.226 .