A foreign facility that manufactures, processes, packs, or holds food for U.S. consumption generally must register if it is not exempt. A foreign facility that is required to register must also designate a U.S. Agent for FDA communications.

Required food facility registrations must be renewed during the period from October 1 through December 31 of each even-numbered year. A registration that is not renewed by the end of the renewal period is considered expired.

Failure to register, update, or cancel a food facility registration when required is a prohibited act under the FD&C Act. Food from a foreign facility that is required to register but has not done so is subject to refusal when imported or offered for import into the United States.

FSVP is the FDA food-importer framework in 21 CFR Part 1, Subpart L. Covered FSVP importers must evaluate known or reasonably foreseeable hazards, evaluate foreign-supplier performance, approve suppliers, conduct appropriate supplier-verification activities, take corrective actions when needed, and maintain required records.

The FSVP importer is generally the U.S. owner or consignee of the food at the time of entry. If there is no U.S. owner or consignee, the FSVP importer can be the U.S. agent or representative of the foreign owner or consignee when the regulatory conditions are met. Exemptions and modified requirements apply in certain circumstances.

Yes, for a foreign food facility that is required to register. The U.S. Agent must reside or maintain a place of business in the United States and serves as a communications link between FDA and the foreign facility.

Prior Notice gives FDA advance information about food offered for import into the United States. It generally must be submitted before arrival unless an exemption applies. Minimum advance filing times vary by transportation method, including 2 hours by road, 4 hours by rail or air, and 8 hours by water.

No. Food facility registration is not FDA product approval, certification, clearance, or endorsement. FDA does not preapprove most conventional food products before marketing.

A warehouse or storage facility that holds food for human or animal consumption in the United States generally must register if it meets the definition of a facility and no exemption applies. The facts of the operation matter, so the registration requirement should be evaluated for the specific location.

Dietary supplements are regulated as a category of food under the FD&C Act. Facilities that manufacture, process, pack, or hold dietary supplements may be subject to food facility registration, and imported supplements may be subject to FSVP, including modified requirements in certain circumstances.

HACCP is a preventive food-safety system built around hazard analysis and critical controls. FDA HACCP regulations specifically apply to seafood and juice. Many other food facilities are instead subject to FSMA preventive-controls requirements under 21 CFR Part 117 or Part 507, unless an exemption or modified requirement applies.

Yes. FDA does not require a third-party registrar and does not charge a government fee for food facility registration, renewal, updates, or cancellation. A facility may file directly, or it may authorize another individual to submit the filing when permitted.

Timing depends on having complete facility information, a valid UFI such as the facility's DUNS number, and any required U.S. Agent confirmation. FDA Registration Assistance typically prepares routine registrations within 24–48 hours after complete information is available, but FDA or identifier processing can affect timing.

FDA regulates most human and animal foods offered in U.S. interstate commerce, including many packaged foods, beverages, dietary supplements, ingredients, pet foods, and animal feeds. Meat, poultry, and certain processed egg products are primarily regulated by USDA, and additional exemptions or commodity-specific rules can apply.

The Food Safety Modernization Act shifted federal food-safety oversight toward prevention. Depending on the operation, FSMA requirements can include preventive controls, produce-safety standards, FSVP, sanitary transportation, food-defense requirements, and biennial food facility registration renewal.

FDA Registration Assistance provides what industry commonly calls FSVP Agent and FSVP compliance services. FDA regulations define the FSVP importer rather than creating a separate FSVP Agent registration category, so the legally responsible party and any authorized representative role must be structured correctly for the shipment.

An FDA food-facility inspection can review facility conditions, sanitation, manufacturing practices, food-safety plans, preventive controls, records, supplier controls, labeling, and other requirements that apply to the operation. The scope depends on the facility, product, and regulatory program.

A private-label brand owner does not automatically need a food facility registration merely because its name is on the product. Registration applies to covered facilities that manufacture, process, pack, or hold food. A brand owner or importer may have separate obligations such as FSVP, Prior Notice, labeling, and supplier oversight.

Yes. We can review the applicable Import Alert, entry history, underlying compliance issue, testing or corrective-action records, and FDA requirements for requesting removal from detention without physical examination when a removal pathway is available.

No. FDA does not charge a government fee for initial food facility registration, updates, biennial renewal, or cancellation. Professional registration and U.S. Agent service fees are separate private service fees.

FSVP depends on whether you meet FDA's definition of the FSVP importer for a covered imported food and whether an exemption or modified requirement applies. The analysis should consider the U.S. owner or consignee, foreign supplier, food, intended use, and any applicable exemption.

Yes. We can manage biennial food facility renewal, registration updates, U.S. Agent representation for foreign facilities, FDA correspondence, and separately scoped services such as FSVP, Prior Notice, labeling, and import-compliance support.

The required records depend on the business and food. They may include facility registration information, U.S. Agent designation, FSVP records, food-safety plans, supplier-verification records, HACCP records, labeling documentation, Prior Notice records, and commodity-specific filings such as FCE/SID.

Professional support can help identify the correct facility role, U.S. Agent requirement, UFI information, product categories, related import obligations, and renewal or update deadlines before filing. FDA Registration Assistance also provides ongoing support when the service scope includes representation or compliance management.

Commercial processors of low-acid canned foods and acidified foods in hermetically sealed containers can be subject to FDA's FCE registration and scheduled-process filing requirements under 21 CFR Parts 108, 113, and 114. The requirement depends on the product and process; it does not apply to every canned or shelf-stable food.

FDA Registration Assistance charges $858 per year for its Foreign Food Facility Registration and U.S. Agent service package. The annual professional service includes registration filing support, ongoing U.S. Agent representation, FDA correspondence support, registration updates, and biennial renewal management when due. FDA itself charges no government fee for food facility registration.

FDA requires a Unique Facility Identifier recognized as acceptable for food facility registration. FDA currently recognizes the Dun & Bradstreet DUNS number as an acceptable UFI and instructs facilities to obtain or verify the facility's DUNS number before registration.

Most changes to required food facility registration information must be submitted to FDA within 60 calendar days. A change in ownership is treated differently: the former owner must cancel the existing registration within 60 days and the new owner must register the facility.

FDA Registration Assistance works with food businesses worldwide and provides remote registration, U.S. Agent, FSVP, labeling, and import-compliance support for domestic and international clients.