FDA Food Facility Registration

Find this page at:
go.ncsu.edu/readext?996960

en Español / em Português

Español

El inglés es el idioma de control de esta página. En la medida en que haya algún conflicto entre la traducción al inglés y la traducción, el inglés prevalece.

Al hacer clic en el enlace de traducción se activa un servicio de traducción gratuito para convertir la página al español. Al igual que con cualquier traducción por Internet, la conversión no es sensible al contexto y puede que no traduzca el texto en su significado original. NC State Extension no garantiza la exactitud del texto traducido. Por favor, tenga en cuenta que algunas aplicaciones y/o servicios pueden no funcionar como se espera cuando se traducen.

Português

Inglês é o idioma de controle desta página. Na medida que haja algum conflito entre o texto original em Inglês e a tradução, o Inglês prevalece.

Ao clicar no link de tradução, um serviço gratuito de tradução será ativado para converter a página para o Português. Como em qualquer tradução pela internet, a conversão não é sensivel ao contexto e pode não ocorrer a tradução para o significado orginal. O serviço de Extensão da Carolina do Norte (NC State Extension) não garante a exatidão do texto traduzido. Por favor, observe que algumas funções ou serviços podem não funcionar como esperado após a tradução.

English

English is the controlling language of this page. To the extent there is any conflict between the English text and the translation, English controls.

Clicking on the translation link activates a free translation service to convert the page to Spanish. As with any Internet translation, the conversion is not context-sensitive and may not translate the text to its original meaning. NC State Extension does not guarantee the accuracy of the translated text. Please note that some applications and/or services may not function as expected when translated.

Estoy de Acuerdo / Eu concordo / I agree

Collapse ▲

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.

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