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Yes. Most non-U.S. facilities that manufacture, process, pack, or hold food for U.S. consumption must register with FDA.

FDA refers to these businesses as foreign facilities and generally requires registration before food is imported into the United States.

This requirement applies to many food manufacturers, processors, warehouses, and packers that ship products to the U.S. Registration helps FDA identify facilities involved in the food supply chain. Certain exemptions may apply depending on the facility type and activities performed.

What you need:

• Facility name and address
• Business ownership details
• Food categories handled
• Facility contact information
• Designated U.S. Agent for FDA communications

Compliance note: Exporting food to the United States without a food facility registration, when applicable, will result in detention at the port of entry and ultimately refusal of the shipment(s).

Facilities that manufacture, process, pack, or hold food for U.S. consumption generally must register.

This can include food manufacturers, ingredient suppliers, processors, and storage warehouses. The food definition also includes dietary supplements, beverages, infant formula, and animal food. Registration requirements depend on the facility’s activities, not simply the products sold.

Yes. Some farms, restaurants, retail food establishments, and certain other facilities may be exempt.

FDA regulations include specific exemptions based on facility type and operations. Whether an exemption applies depends on the facts of each situation. Companies should review FDA guidance and applicable regulations before assuming they are exempt.

The FDA may invalidate a facility’s registration for various reasons, from lack of current information to missing renewal deadlines. Without a correct and complete registration, your company could face shipment detentions, refusals, fines, and other enforcement actions.

Registrar Corp will verify FDA registration at no cost so that suppliers can quickly determine whether their registrations are valid and in compliance with FDA’s requirements.

Verify your registration today for free.

Yes. Non-U.S. food facilities required to register with FDA generally must designate a U.S. Agent.

The U.S. Agent serves as a communications contact between FDA and the foreign facility. FDA may use the U.S. Agent for routine communications and certain regulatory matters. The agent must maintain a physical presence in the United States.

What you need:

• U.S. Agent name
• U.S. address
• Email address
• Telephone number

A U.S. Agent acts as a communication point between FDA and a foreign facility.

The role may include receiving communications from FDA and helping facilitate contact with the facility when needed. Companies should understand the scope of services offered by any U.S. Agent provider.

Learn more at: https://www.registrarcorp.com/us-agent/

Yes. FDA registration information can generally be updated when a U.S. Agent changes.

Facilities should keep registration information current whenever significant details change. Timely updates help ensure FDA can reach the correct contacts if needed.

FDA typically requires facility identification, contact information, and food-related business details.

Required information varies based on the facility and registration status. Preparing complete information before starting the process can help avoid delays and corrections.

What you need:

• Facility legal name
• Physical address
• Owner/operator details
• Food product categories
• U.S. Agent information (for foreign facilities)

FDA currently requires a recognized Unique Facility Identifier (UFI) for food facility registration submissions.

FDA has historically accepted DUNS numbers as a UFI. Requirements may change over time, so facilities should confirm current FDA requirements before submitting or updating registrations.

The time required varies depending on the completeness and accuracy of the information provided and the time it takes to obtain the DUNS number.

Preparation often takes longer than submission itself. Missing information, verification issues, or questions regarding facility activities can extend timelines.

Yes. FDA permits authorized individuals to submit registrations on behalf of a facility.

Many companies choose to work with compliance service providers for administrative support. The facility owner, operator, or agent in charge remains responsible for ensuring information submitted is accurate.

Yes. Facilities required to maintain FDA food facility registration generally must complete biennial renewal during the 2026 renewal period.

FDA requires food facility registrations to be renewed during even-numbered years. The 2026 renewal period runs from October 1 through December 31, 2026. Facilities should review registration information, U.S. Agent details, and facility records before the renewal window opens to help ensure information is accurate and current.

What you need:

• Current registration information
• Facility contact details
• U.S. Agent information
• Updated ownership or operational information, if applicable

Compliance note: Failure to complete a required renewal during the designated renewal period may affect a facility’s registration status.

Learn more about compliance requirements and how to get assistance at: https://www.registrarcorp.com/services/food-safety/fda-compliance-for-food-exports/

Registration information should be updated when required information changes.

Examples may include changes to facility ownership, address, contact details, product activities, or U.S. Agent information. Maintaining current records helps support ongoing compliance.

FDA registration must be canceled when a facility no longer exports foods to the U.S.

Specific obligations depend on the facility’s circumstances. Companies should review FDA requirements and maintain accurate registration records throughout the facility lifecycle.