FDA RegistrationInstructions and Requirements*Please follow the steps below to: (1) file a new registration for your facility OR (2) provide us with the required information for a facility you have already registered. *See the note about Additional Facility Registrations at the bottom of this page if you wish to add another facility to your existing membership and appoint AFI as the agent for FDA registration. (1) If your facility is not yet registered with FDA: We can handle the filing for you. Please complete the Facility Registration Form and Food Product Categories form (download links below), and return to us when you are ready to proceed. Be sure to return both forms duly completed. We cannot file the registration without knowing the products handled as well as the respective plant activities. (The Food Product Categories form is excerpted from the official FDA form; it is three pages, numbered 4 through 6.) Do not submit the Facility Registration Form without the required DUNS number, which you can look up here. (The DUNS number is also called the "Unique Facility Identifier" or UFI number. The terms refer to the same ID number.) Important note regarding DUNS numbers: The information submitted for the FDA registration (specifically the company name and address) must match the information in the Dun & Bradstreet database exactly, including punctuation and capitalization (upper/lower case letters); otherwise, the DUNS number will be rejected. We recommend that you obtain a copy of the Dun & Bradstreet record for your facility to ensure that you provide us with the correct information for the registration. After we have received your completed forms, the information will be filed with FDA and your registration number returned to you within a day or two. Document Links
| (2) If your company's facility has already been registered with FDA: Please complete the Facility Registration Form (download link below left) and return it to us to confirm that you wish to have AFI serve as the U.S. agent for your facility. The signature of a company officer or other responsible individual is required to confirm agreement to the terms of service. It is not necessary to return the Food Product Categories List form if your registration has already been filed. Be sure to include the registration number and PIN found in section 1 of the official registration record. After you have submitted the Facility Registration Form to us, you may then change the agent to AFI. Enter the following information in "Section 7: United States Agent" of the registration record: Check off "Association" from the list of options. NAME OF U.S. AGENT: Association of Food Industries, Inc. AFI's U.S. agent ID number will be provided upon request. When we are contacted by FDA, we will confirm this designation as soon as possible. Please do not change the U.S. agent to AFI before submitting the Facility Registration Form. We will not confirm to FDA that AFI will serve as the U.S. agent for unknown companies. Detailed instructions for updating your registration through FDA's Industry Systems web site can be downloaded via the link at left. Alternatively, we can update the registration for you if you provide your registration number and PIN so that we can link it to our account. The PIN can be found in section 1 of the registration record. |
*Additional Facility Registrations
Foreign Supplier membership in the association includes the FDA registration service for one facility (factory, packing plant, warehouse, etc.) at no extra charge. Additional facilities may be appended to your membership. Please follow the instructions above to add another facility to your membership.
Each additional facility registered with AFI as the U.S. agent incurs an annual fee of $175. You will be invoiced for the additional facility fee upon submission of the completed Facility Registration Form.
Please note that an additional facility must be wholly owned and operated by the AFI member company. It cannot be a separate legal entity, such as a supplier, service provider or other business partner. Such a company must obtain its own individual Foreign Supplier membership with AFI in order to have AFI serve as the U.S. agent for FDA registration. Click here to access membership information and to submit an application for another company.
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