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Food, Beverage, & Dietary Supplement FDA Facility Registration Interest Form

Include suffix e.g, LLC, Limited, Inc, Pte Ltd, Pvt Ltd, etc.
If you don't have a DUNS, we can help. Type 'No DUNS' in the field.
This should be the facility address where the products are manufactured, packed, processed, or stored.
You will receive a receipt code to this email to confirm the facility registration. Please provide the correct email address.
Include Country Code
I confirm that facility is engaged in the manufacturing processing packing or holding of foods
Was this facility was previously registered with the FDA?
I Agree With The Terms and Conditions and Scope of Services Below

Food, Beverage & Dietary Supplement FDA Facility Registration

Who Must Register?

Under the U.S. FDA Bioterrorism Act of 2002, all foreign and domestic facilities that manufacture, process, pack, or store food, beverages, and dietary supplements sold in the U.S. market are required to register with the FDA. This registration leads to the issuance of a Food Facility Registration (FFR) number. Furthermore, intermediary merchant companies, such as traders, importers, or distributors, must register with the FDA if they handle food in a holding facility or warehouse.
After registering, the FDA assigns an 11-digit registration number to the food facility. This number identifies the manufacturing or trading firm and is necessary for U.S. customs clearance. Due to the FDA’s confidentiality policy, food facility registration data remains private and is never published publicly. Consequently, the FDA’s initial registration or renewal notice, sent via an official FDA email, is the only proof that the registering firm will receive.

Required Information to Obtain an FFR

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)

Food, Beverage & Dietary Supplement FDA Facility Registration Process

Cost: $349

  • Step 1
    Complete the initial form below, and tell us about your facility
  • Step 2
    We will issue you a short and simple questionnaire to collect your company and facility details
  • Step 3
    We prepare a draft for your review, and after receiving your approval, we submit it to the FDA
  • Step 4
    We will work with the FDA to get your facility registered (1-3 days)
  • Step 5
    Your facility will be FDA registered, and you will receive an FDA registration number, and we issue your certificate
  • Step 6
    After FDA verification, your FDA registration number is assigned, and we issue your certificate
A Few Important Things To Note:- Our fee includes U.S. Agent services for foreign companies. We provide professional U.S. Agent representation to facilitate compliance and communication with the U.S. FDA. No additional fees required for U.S. Agent services.- Food facilities must renew their registrations every even-numbered year between October 1 and December 31. We work with you to manage this process to ensure your registration remains active and up to date, so we can avoid border issues.- The FDA requires foreign facilities to provide a D-U-N-S Number for registration. If you don’t have one, we can assist in obtaining it for an additional fee.
Food & Beverage FDA Registration Terms and Conditions / Scope of Services

Food Facility Registration Renewal & Updates

FDA-registered food facilities must renew their registration every even-numbered year, between October 1 and December 31—regardless of the initial registration date. For example, a facility registered in 2023 must renew by the end of 2024, then again in 2026, and so on.
In addition to the biennial renewal requirement, food facilities must update their FDA registration within 60 days of any changes. These changes may involve factors such as relocation, a change in ownership, updates to product categories, or changes to the DUNS number or associated details. If a registered food facility permanently ceases operations, it must cancel its FDA registration within 60 days.

Role of U.S. FDA Agent

Foreign companies are required to appoint a U.S. agent to register with the FDA. This agent serves as the primary contact for all FDA communications and should be informed in FDA compliance requirements. Even minor errors during the registration process can lead to delays or issues when products arrive at U.S. ports. Additionally, appointing an independent FDA agent, rather than a trade partner, can also help prevent potential conflicts of interest.
To clarify, the FDA neither approves nor disapproves U.S. agent firms. During registration, renewal, and update processes, the FDA verifies that the designated agent has agreed to the role. After the agent accepts and the FDA completes its review, the company receives an 11-digit Food Facility Registration (FFR) number. However, this depends on the accuracy of the submitted Unique Facility Identifier (UFI) number.

FDA Registration Certificate

Although the FDA does not issue certificates, upon completion of registration, FDA Agent Pro will provide an FDA registration certificate valid for one year, which 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.

FDA Prior Notice

Before any food shipments enter the United States, a Prior Notice shall be filed with the FDA. This requirement applies to all food items, including samples intended for trade shows or personal use. After filing the Prior Notice, the submitter will receive a confirmation number to be used during the shipment process. Firms can access the FDA Prior Notice portal, follow the instructions to create an account, and submit their shipment prior notices. Alternatively, the company’s customs broker or international shipping firm (e.g., DHL, FedEx, TNT) can file the Prior Notice on the company's behalf.