Frequently Asked Questions
Find quick answers regarding FDA food facility registration, U.S. agent services, and compliance processes.
Who needs an FDA Food Facility Registration?
Any domestic or foreign facility that manufactures, processes, packs, or holds food for human or animal consumption destined for the United States market must hold a Food Facility Registration.
This applies unless they are exempt under 21 CFR 1.226 (e.g., some farms and retail food establishments).
What constitutes a “facility”?
A facility generally refers to an establishment under one ownership at one physical location that manufactures, processes, packs, or holds food for human or animal consumption for the United States market.
Facilities can include manufacturing plants, warehouses, cold-storage facilities, and other establishments that conduct activities covered by FDA’s food facility registration requirements.
Do all food facilities require a US agent for a Food Facility Registration?
Only foreign (non-US-based) food facilities need an agent appointed at the time of registration.
In fact, is a mandatory prerequisite for a foreign (non-US-based) food facility to receive a Food Facility Registration number from the FDA.
What is a DUNS number?
A DUNS (Data Universal Numbering System) is a business identifier number issued by Dun & Bradstreet.
It is a unique nine-digit identification code assigned to a single business entity and serves as your UFI (Unique Facility Identifier) with the FDA.
Can I obtain my FDA Food Facility Registration without a DUNS number?
Generally, no. All food facilities need an FDA Unique Facility Identifier (UFI) number for registration, and the DUNS is the only UFI accepted by FDA for food facility registrations.
Can a FEI number be accepted as a UFI (Unique Facility Identifier) for a Food Facility Registration?
No. A FEI (FDA Establishment Identifier) number is an internal code assigned by the FDA to track facilities in their system; however, it does not accept it as a Unique Facility Identifier (UFI) number for the Food Facility Registration.
The only UFI accepted by the FDA is the DUNS number issued by Dun & Bradstreet.
Do I need a US-based agent to obtain an FDA Food Facility Registration?
Yes, if you are a foreign food facility, is it required to register with FDA.
A foreign facility must designate a U.S. Agent who resides or maintains a place of business in the United States. The U.S. Agent serves as the communication link between the foreign facility and FDA.
If you operate a domestic U.S. facility, you generally do not need a U.S. Agent for your Food Facility Registration.
How long does the Food Facility Registration last?
The registration is valid from the date of approval until the end of every even-numbered calendar year, on which every FDA Food Facility Registration needs to renew their registries (also called biennial renewal).
Food Facility Registrations must be renewed during the renewal period from October 1 through December 31 of every even-numbered year, such as 2026, 2028, 2030, and so on.
Does my Food Facility Registration number expire?
The FDA registration number itself generally remains the same when a current registration is properly renewed. FDA does not issue a new registration number simply because a facility completes its biennial renewal.
However, the registration must remain up-to-date, and comply with FDA’s renewal requirements.
What happens if I don’t do the Biennial Renewal in time?
If the facility fails to renew its registration on time, the registration may expire and be deemed inactive.
An inactive or expired registration can create significant problems for a facility importing food into the United States. Food offered for import from a facility that is not properly registered may be subject to FDA regulatory action, including possible refusal of admission.
To help avoid unnecessary delays, businesses should make sure their FDA registration remains current and that all required information is kept accurate and up to date.
Which industries do you serve for FDA registration?
We specialize in FDA Food Facility Registration services for food and beverage manufacturers.
This includes businesses involved with products such as: General packed goods, fruits and vegetables, seafood, dairy products, bakery goods, candy and confectionery, dietary supplements (including vitamins and minerals),foods involving substances that are Generally Recognized as Safe (GRAS) animal foods and drinks such as bottled water, soft drinks, beer, wine and spirits.
Please note that certain products may also be subject to requirements by other U.S. federal agencies or additional FDA regulations. Food Facility Registration alone does not determine whether a particular product is legally permitted for sale or importation in the United States.
Does this FDA Food Facility Registration certificate make my products automatically “FDA Approved”?
No. An FDA Food Facility Registration does not constitute FDA approval, certification, endorsement, or authorization of your products.
Registration identifies a facility with FDA and is a regulatory requirement for facilities that fall within the scope of the registration rules. However, registered facilities and their products must still comply with all other applicable U.S. requirements.
An FDA Food Facility Registration should therefore never be represented as an “FDA-approved product” certification.
Does my DUNS number expire?
No. A DUNS number does not have a routine expiration date.
However, the business and facility information associated with the DUNS record should be kept accurate and up to date. Changes to business information, such as the facility’s address or other identifying information, may need to be updated in the appropriate records and FDA registration.
How long does an FDA Food Facility Registration take to be issued?
Once all required information is available, including the applicable DUNS number, we typically prepare and submit most Food Facility Registration applications within 2 to 3 business days.
The overall time required for a registration to be confirmed may vary depending on the accuracy and completeness of the information provided by the customer, FDA verification requirements, the availability of required information, and whether FDA requests additional information.
Our processing time should not be interpreted as a guarantee of the time FDA will require to confirm a registration.
How long does it take for a DUNS number to be issued?
Dun & Bradstreet cites up to 30 days for its issuance. DUNS processing times can vary depending on the business industry, the business information available for verification, and Dun & Bradstreet’s own reviewing process.
Based on our experience, we often obtain DUNS numbers much faster than the maximum timeframe when the business information is complete and easily verifiable.
Because DUNS numbers are issued by Dun & Bradstreet and not by us, we cannot guarantee a specific issuance timeframe.
Do you guarantee the obtention of DUNS and FDA Food Facility Registration numbers?
No. The issuance of either identifier is subject to the requirements and verification procedures of the respective organization.
Our role is to review the information provided by the customer and professionally prepare and submit the registration request to help avoid unnecessary delays.
We cannot guarantee the issuance of a DUNS number or FDA Food Facility Registration number, nor can we guarantee a specific processing timeframe.
Does the FDA issue an official “certificate of registry”?
No. FDA does not issue a frameable “FDA certificate” or diploma type of document
FDA provides a watermarked confirmation document of the facility’s Food Facility Registration, including its FDA registration number and registration information.
If you would like a certificate-style document for your business records, we can provide an unofficial digital certificate for informational or display purposes that you can print and frame.
Such certificate is a private document and does not constitute an official FDA document, FDA endorsement, or product certification.
Are you affiliated with the FDA?
No. We are an independent private company and are not affiliated with, endorsed by, sponsored by, or acting on behalf of the U.S. Food and Drug Administration.
FDA Food Facility Registration assistance, DUNS assistance, and U.S. Agent services offered by private companies are independent services and are not FDA services.
Do you offer standalone DUNS number acquisition services?
Yes.
We can assist with obtaining a DUNS number if that is the only service you require.
Please note that the DUNS number is issued by Dun & Bradstreet, not by our company.
Do you offer standalone FDA Food Facility Registration services if I already have a DUNS number?
Yes.
If you already have a valid DUNS number, we can assist with preparing and submitting your FDA Food Facility Registration.
We will review the information required for the registration and help ensure that the application is properly prepared before submission.
Do you offer standalone US Agent representation services?
Yes.
For foreign food facilities that are required to have a U.S. Agent, we can provide U.S. Agent services for the applicable service period.
Our U.S. Agent service is limited to the responsibilities and communications associated with the FDA Food Facility Registration U.S. Agent role and does not automatically include legal representation, regulatory defense, or other consulting services unless separately agreed in writing.
I have already registered my food facility with another service provider. Can I switch to your service and have you do my biennial registration renewal?
Yes.
You can change the private service provider assisting with your FDA Food Facility Registration.
We can assist with the renewal of an existing registration provided that we have sufficient documentation from your previous registration, such as your FDA registration confirmation document.
What is the role of a U.S. Agent?
A U.S. Agent, we serve as a communication link between FDA and the foreign facilities we represent and promptly relay FDA communications to our clients.
The U.S. Agent’s role does not replace the foreign facility’s responsibility to comply with applicable FDA requests and requirements directly.
Are you compliant US Agents as per FDA requirements?
Yes. Our U.S. Agent service is structured to meet the applicable FDA requirements for a Food Facility Registration U.S. Agent.
We maintain a physical U.S. business location and personnel who are physically present in the United States and available during business hours to receive applicable communications.
As my US agent, will you be my business’s spokesperson with the FDA?
No. Our U.S. Agent service is limited to the responsibilities associated with the FDA Food Facility Registration U.S. Agent role, serving as a communication link between your foreign facility and FDA, to receive and relay relevant FDA communications to your business.
The foreign facility remains responsible for responding to FDA and for complying with all applicable regulatory requirements.
As my US Agent, will you be offering legal representation for my business with the FDA?
No. Our U.S. Agent service is not legal representation and does not create an attorney-client relationship.
Our role is to serve as the designated U.S. Agent and communication link for the foreign facility in connection with its FDA Food Facility Registration.
If you require legal representation, regulatory defense, FDA enforcement assistance, or specialized regulatory advice, you should consult an appropriately qualified attorney or regulatory professional.
As my US Agent, will you be responsible for any liabilities of my business with the FDA?
No. Our appointment as U.S. Agent does not transfer the foreign facility’s regulatory compliance obligations to us.
The registered foreign facility remains responsible for the accuracy of its registration information and for complying with applicable FDA requirements governing its operations, facilities, and products.
Take the First Step Toward Your Success Today
Your FDA compliance journey doesn’t need to be complicated. Leave us the heavy load so you can focus on growing your business.