FDA LISTING INC: EXPERIENCED ADVISORS FOR FULL-SERVICE FDA REGISTRATION & COMPLIANCE
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U.S. FDA Registration
& Labeling Compliance Assistance
FDA Facility Registration for Food, Beverage, and Dietary Supplements
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The U.S. FDA Bioterrorism Act of 2002 requires all foreign and domestic facilities that manufacture, process, pack, and store food, beverages, and dietary supplements marketed in the U.S. to register with the FDA and obtain an FDA Food Facility Registration (FFR) number. The FDA registration aims to prevent food supply-related threats, hazards, and emergencies. The FDA food facility registration is also required for intermediary merchant companies, such as traders and US importers, if they handle foods in a holding facility or warehouse
Upon registration, a food facility receives an 11-digit registration number, which identifies the firm with the FDA and is required in the U.S. customs clearance process. The FDA does not publish the FDA food facility registration data on any public database due to confidentiality, and the FDA initial registration or renewal notice sent by an official FDA email is the only proof you will receive from the FDA.
What information Is required & what are the steps?
When applying for a food facility registration number, the following information is required:
● Unique Facility Identifier (9-digit DUNS number)
● Facility name, address, and emergency contact
● Information on the owner, operator, or agent in charge
● General product categories and types of activities conducted
● Any trade names (brand names)
● U.S. Agent who has accepted the designation (for international facilities)
The FDA Food Facility Registration Steps:
1- Obtaining a DUNS number via the D&B portal or partner office
2- Verification of facility information and products
3-Submission of the facility info to FDA to get the FFR number
4- Issuing the Certificate of registration, valid for one year
The FDA registration is generally completed within 1-2 days if all information, including the DUNS number (known as UFI), is adequately provided.
Food Facility Registration Renewal & Updates
The FDA requires that all registered food facilities renew every even-numbered year between October 1st and December 31st. Regardless of when a food facility was registered, such registration must be renewed at the end of the next even-numbered year. For example, if the facility was registered at the end of 2023, it needs to be renewed at the end of 2024, 2026, and so on. Furthermore, if there are any changes to the facility information, such as relocation, change of owner or product categories, or changes to DUNS info, the food facility must update the registration with the FDA within 60 days. Similarly, If the facility ceases operation, the registered food facility must cancel its registration within 60 days
U.S. FDA Agent
Foreign companies must appoint a U.S. agent to be able to register with the FDA. The agent can serve as the primary contact with the FDA on behalf of a registered company. Simple mistakes during online registration can create critical adverse situations when the food items are at the U.S. port of entry. Therefore, it is crucial that the U.S. agent understands FDA regulations and can advise the company on FDA compliance requirements. Additionally, an independent FDA agent can prevent potential conflicts of interest when using a trade partner as an agent.
To clarify, the FDA neither approves nor disapproves US agent firms. During initial registrations, renewals, and updates to information about US agents, the FDA will verify that the person or company identified as the US agent for the foreign facility has agreed to serve as the agent. After the US agent accepts their designation and the FDA reviews and approves the submission, you will receive an 11-digit food facility registration number (FFR), granted that the UFI number provided during registration is accurate.
FDA Registration Certificate
Although the FDA does not issue any certificates, upon completion of registration, FDA Listing Inc. will provide an FDA registration certificate valid for one year and can be used as proof of registration. A copy of the certificate can be used to confirm registration with U.S. customs, importers, distributors, and other commercial outlets.
U.S. Shipment's Prior Notice with the FDA
The FDA requires a Prior Notice to be filed before food shipments enter the U.S., including food samples for trade shows or consumption. After filing the Prior Notice, you will receive a confirmation number, which will be used for shipment release. You can access the FDA Prior Notice portal, follow instructions to create an account and submit your shipment prior notices. Alternatively, your company’s customs broker or international shipping firms (e.g., DHL, FedEx, TNT) can file the Prior Notice.
Service Details & Fees
Food Facility Registration
Time Required
DUNS Number
U.S. Agent
FDA Registration Certificate
FDA Registration Updates
395 USD
1-2 Days
95 USD
_______ Related Services _______
Frequently Asked Questions (FAQ)
Most food facility registrations are complete within 1-2 days. A common reason for the delay is when the DUNS address does not match the provided facility address.
No, the FDA does not charge initial or annual fees for food facility registration. The only fees paid will be those of registering agency service fees.
No product testing or laboratory reports are required during FDA registration. The manufacturer is always responsible for the safety of the food item entering the US market.
No submission of food safety documentation or GMP is required during FDA registration.
Since 2023, the FDA has been regularly reviewing FFR records and canceling registrations if the DUNS number is an inaccurate representation of the FFR data.
? If you are a merchant office involved in the shipment paperwork but the food items are shipped directly to the destination by the original manufacturer, your facility does not need to be registered with the FDA. If you are an intermediary firm taking ownership of food items, such as handling or storing them in a warehouse, you must register with the FDA.
Frequently Asked Questions (FAQ)
Most food facility registrations are complete within 1-2 days. A common reason for the delay is when the DUNS address does not match the provided facility address.
No, the FDA does not charge initial or annual fees for food facility registration. The only fees paid will be those of registering agency service fees.
No product testing or laboratory reports are required during FDA registration. The manufacturer is always responsible for the safety of the food item entering the US market.
No submission of food safety documentation or GMP is required during FDA registration.
Since 2023, the FDA has been regularly reviewing FFR records and canceling registrations if the DUNS number is an inaccurate representation of the FFR data.
If you are a merchant office
involved in the shipment paperwork but the food items are shipped directly to the destination
by the original manufacturer, your facility does not need to be registered with the FDA. If you
are an intermediary firm taking ownership of food items, such as handling or storing them in a
warehouse, you must register with the FDA.
Service Details & Fees
Food Facility Registration
395 USD
Time Required
1-2 Days
DUNS Number
95 USD
U.S. Agent
FDA Registration Certificate
FDA Registration Updates
_______ Related Services _______