21 CFR Part 1, Subpart H · Bioterrorism Act 2002
FDA Food Facility Registration Requirements
Food facilities that manufacture, process, pack, or hold food for consumption in the United States must register with the FDA. This applies to both domestic and foreign facilities. Here is everything you need to know about who must register, how to register, and how to stay compliant.
Who Must Register
Under Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Bioterrorism Act of 2002 and strengthened by FSMA in 2011, the following facilities must register with the FDA:
- Domestic food facilities that manufacture, process, pack, or hold food for human or animal consumption in the U.S.
- Foreign food facilities that manufacture, process, pack, or hold food for consumption in the United States
- Co-packers and contract manufacturers who produce food products for other brands
Registration is required even if you export through a third-party distributor and do not ship directly to the U.S. What matters is whether your facility produces food intended for the U.S. market.
Exemptions
The following types of facilities are exempt from FDA registration requirements:
- Farms (facilities that grow, harvest, or raise food)
- Restaurants and retail food establishments that sell directly to consumers
- Fishing vessels that do not process fish (other than freezing)
- Facilities regulated exclusively by the USDA (e.g., meat, poultry, egg products)
What Information Is Required
Facility nameLegal name of the facility as it appears on official documents
Physical addressStreet address of the facility — P.O. boxes are not accepted
Emergency contact24-hour emergency contact name and phone number
Food categoriesTypes of food manufactured, processed, packed, or held at the facility
U.S. AgentFor foreign facilities: name, address, phone, and email of your U.S. Agent
Owner/operatorName and contact information of the facility owner or operator
How to Register
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1
Go to the FDA's Unified Registration and Listing System (FURLS) at access.fda.gov. Create an account if you do not already have one.
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2
Select "Food Facility Registration" and complete all required fields including facility name, address, food categories, and (for foreign facilities) your U.S. Agent information.
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3
Submit the registration. You will receive a registration number immediately upon completion. This number should be kept on file — you may need to provide it to your U.S. importer or customs broker.
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4
Renew your registration every two years during October 1 – December 31 of each even-numbered year (2024, 2026, 2028, etc.). Failure to renew results in the registration becoming inactive.
Consequences of Not Registering
Importing food from an unregistered foreign facility is a prohibited act under the FD&C Act. The consequences include:
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Shipments refused entry at the U.S. border by CBP and FDA✕
Detention Without Physical Examination (DWPE) — future shipments automatically held✕
Civil monetary penalties of up to $10,000 per violation per day for domestic violations✕
Criminal penalties in cases of knowing and willful non-compliance✕
Suspension of registration if the facility is linked to a serious adverse health consequence