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FDA Food Facility Registration

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Initial Facility Registration

The Food and Drug Administration (FDA) requires registration from all facilities and operations that manufacture, pack, or hold food for human or animal consumption. Registration is required prior to the commercial facility starting their operations, regardless if the product will enter into interstate commerce. The facility’s owner, operator, or agent in charge may authorize an individual to register on their behalf. It should be noted that the list of registered facilities, registration documents and information included in registration documents are not available to the public, i.e., the information is not subject to public disclosure under the Freedom of Information Act.

Information required to complete an FDA food facility registration

Facility name, address, phone number, and emergency contact phone number Parent company name, address, and phone number (if the facility is a subsidiary of the parent company) The facility’s acceptable Unique Facility Identifier All trade names the facility uses
Name, address, and phone number of the owner, operator, or agent in charge Email address of the owner, operator, or agent in charge Applicable food product categories of any food manufactured/processed, packed, or held at the facility. The type(s) of activity at the facility for each food product category, as noted below
A statement in which the owner, operator, or agent in charge provides an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. A statement in which the owner, operator, or agent in charge certifies that the information submitted is true and accurate.

Food processing operations will need to consider every product manufactured in order to appropriately classify themselves within the FDA’s activity types. The food facility registration must include applicable food product categories of any food manufactured/processed, packed, or held at the facility per 21 CFR 1.232(a)(8). If an operation’s processing activities cover multiple category types, all activity types should be selected on the registration. Considerations for each category are further defined in the Guidance for Industry: Questions and Answers Regarding Food Facility Registration.

Food Facility Activity Types

Ambient human food storage warehouse/holding facility Refrigerated human food warehouse/holding facility Frozen human food warehouse/holding facility Interstate conveyance caterer/catering point
Contract sterilizer Labeler/relabeler Packer/repacker Manufacturer/processor
Acidified food processor Low-acid food processor Farm mixed-type facility Salvage operator (reconditioner)
Animal food warehouse/holding facility Other activity (must specify)

Exempt Facilities & Businesses

The following are examples of operations and businesses that are exempt from registering their facility with the FDA. It is not an exhaustive list, but here to serve as the most common exemptions. Many of these definitions can be found in 21 CFR 1.227, unless otherwise noted.

  1. Qualified facilities (also known as very small businesses), as outlined in 21 CFR 117.3
  2. Farms, see Glossary below for definition of farm operations
  3. Retail food establishments
    • Grocery & warehouse stores
    • Restaurants
  4. Home processors, those under Cottage Food Laws
  5. Apiary and beekeeping operations
  6. Non-profit food establishments and operations
  7. Fishing vessels that aren’t processing seafood onboard
  8. Food packaging manufacturers

DUNS Number Requirement: Your Unique Facility Identifier

In addition to a facility registration number, the FDA now requires a unique facility identifier (UFI) to be entered onto applications when facilities are registering or renewing their facility registration (21 CFR 1.232(a)(2)). The UFI is not a substitution for FDA registration numbers. A UFI is required for each address registered with the FDA. As of 2022, data universal numbering system numbers, or DUNS numbers as they are commonly called, are the only FDA-recognized UFI. This 9-digit unique identifying number are used to verify food processing facilities.

Registration with DUNS numbers began during the last biannual period, ending December 31, 2020. However, this required registration date has been extended to December, 31, 2022. Food processing facilities must include this number when registering or renewing their facility to avoid having their FDA registration cancelled.

DUNS numbers can be obtained, free of charge from Dunn & Bradstreet. It can take up to thirty (30) days after your request to receive a DUNS number. Dunn & Bradstreet also offers expedited requests for a fee.

Registration Renewal, Updates and Cancellation

Facilities must have their registration renewed by the owner, operator, or agent in charge of the facility between October 1 and December 31 of every even-numbered year. As of January 4, 2020, the FDA requires all renewals to be submitted electronically on their FURLS database website. The FDA offers an abbreviated registration for operations that do not have changes to their registration; the owner, operator or agent in charge will need to verify information and data before submitting the abbreviated registration.

If a company needs to submit their renewal via fax or the mail, a waiver must be previously granted by the FDA. More information on waivers can be found in Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition).

Updates and cancellation of registration must be communicated to the FDA via the FURLS database within 60 days of changes; this includes changes of ownership.


Resources

NC State Extension publication: FDA Food Processing Facility Registration

FDA Food Processing Facility Registration

Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition)

Food Facility Registration User Guide: Step-by-Step Instructions for Registration

Guidance for Industry: Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal Period

FDA Extends Flexibility for Unique Facility Identifier Requirement for Food Facility Registration through December 2022

Frequently Asked Questions on FSMA

Written By

Kate Nicholas, N.C. Cooperative ExtensionKate NicholasExtension Associate Call Kate Email Kate Food, Bioprocessing & Nutrition Sciences
NC State Extension, NC State University
Page Last Updated: 3 months ago
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