FDA Food Facility Registration

U.S. law requires that all U.S. and foreign facilities that process, pack or hold human or animal food for consumption in the U.S. register with the U.S. Food and Drug Administration (FDA).  All foreign food facilities are required to appoint an agent in the U.S. to serve as a point of contact for FDA.  U.S. Food Imports LLC (USFI) serves as an agent for foreign food facilities and provides registration services.  Please contact us at info@usfoodimports.com if you have any questions or would like more information.


Food Facility Registration: $150

Food Facility Agent Services: $600/year

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Most Facilities Receive a Bioterrorism Number in 48 Hours or Less


Questions and Answers

Q: Are foreign food facilities required to have an agent in the U.S?

Yes.  U.S. law requires that all foreign facilities that process, pack, or hold human or animal food for consumption in the U.S. appoint an agent who serves as a point of contact for FDA.

Q: Does getting registered mean that FDA is approving or certifying my facility?

A: No. The registration only adds your facility to FDA’s database.  All U.S. food facilities and foreign food facilities that process, pack or hold food for human or animal consumption in the U.S. are required to register under law.

Q: Does FDA issue certificates of registration or recognize those issued by private businesses?

A: No.  FDA does not issue certificates of registration and certificates of registration issued by private businesses are not recognized by FDA.  USFI provides all of the businesses it registers with a signed letter indicating the date of registration and the registration number (e.g. Bioterrorism Number) which may be used with customs brokers, importers and others to demonstrate that a facility is properly registered.  The registration number generally must be included in Prior Notice filings for imports.  There is no extra charge for this letter.

Q: What will I receive from USFI after the facility is registered?

A: You will receive a packet from USFI in PDF format which contains a letter indicating the date of registration, the registration number, information about food facility registration requirements and a copy of all information as filed with FDA, including the food facility registration PIN to allow you to login to the FDA registration system.

Q: What are USFI’s fees for food facility registration and agent services?

A: USFI charges $600 annually for food facility registration services and $150 for food facility registration (biennial).

Q: Am I required to reregister a facility every two years?

A: Yes, the Food Safety Modernization Act required all food facilities to reregister with FDA on every even-numbered year.

Registration Number and Exports to the U.S.

The food facility registration number is required to be provided to FDA (in a “Prior Notice” filing) before exported food arrives in the U.S.  U.S. importers, freight providers and others will request this number from foreign facilities.

Keeping Registration Information Up-to-Date

Owners, operators or agents in charge of food facilities are required to update changes to mandatory registration information within 60 calendar days.  If the ownership of the facility changes, the existing registration must be canceled and a new registration submitted.

Many changes are coming to the food facility registration process. View a webinar on FDA’s Final FSMA Food Facility Registration Rule published in July 2016.


FDA Inspections

By registering a facility with FDA, a company has consented to allowing the agency to inspect the facility.

Suspension of Registration

FDA has authority to suspend registration of food facilities. FDA may suspend a facility’s registration if the agency determines that food manufactured, processed, packed, received, or held by a registered food facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals, and the facility created, caused, or was otherwise responsible for the food safety issue; or the facility knew of, or had reason to know of, the food safety issue; and packed, received, or held such food.


Food facilities are required to reregister with FDA from October 1-December 31 of every even-numbered year.  This obligation is separate from the obligation to keep information up-to-date mentioned above.  All food facilities must reregister regardless of whether any of their registration information has changed.  USFI notifies clients at least 60 days in advance of the start of the reregistration period.

Additional information on food facility registration requirements may be found here.