What is a food facility registration?

A food facility registration is the process of registering a business to legally operate as a provider of food products. This registration requires particular information along with certain documents and fees, depending on the state in which your business is located. Once all requirements have been completed, the company will receive an official certification to operate as a retail or wholesale food service provider.

What documents need to be submitted for food facility registration?

For a successful food facility registration, several documents are typically required including the Federal Food Facility Registration form, a copy of the ingredient declarations, label information, and a list of packaging materials. Depending on the type of business and product being produced, additional documents may be requested. Once all requirements have been fulfilled, the facility will receive a letter or email with further instructions concerning next steps and timelines.

What other requirements should I consider before registering my food facility?

When registering your food facility, other considerations should include: the type of business, the type and quantity of products you will be producing, and any health department regulations relating to your food items or manufacturing processes. Additionally, when handling food products that are susceptible to contamination or spoilage, it's essential to identify potential risks and design a Food Safety Plan in order to meet safety standards set by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the Department of Agriculture (USDA).

How will I know when my food facility registration is approved?

Once you have completed the necessary paperwork and sent in all the appropriate documents, your registration should be processed within 10 days. You will receive a confirmation email shortly after submitting the application. If approved, you will also receive an Approved Operators Certificate which serves as proof of registration.

What are the requirements for FDA food facility registration?

The requirements for FDA food facility registration include providing basic information about the facility, such as its name, address, and contact information. Facilities must also provide information about the types of food products they handle and the processes used to manufacture, process, pack, or hold those products. In addition, facilities must designate a U.S. agent for FDA communications and provide emergency contact information. It's important to note that failure to register with the FDA can result in serious consequences, including fines and legal action.

How to register your food facility with the FDA?

To register your food facility with the FDA, you must first create an account on the FDA's Food Facility Registration website. Once you have created an account, you can begin the registration process by providing basic information about your facility and the food products you handle. You will also need to designate a U.S. agent for FDA communications and provide emergency contact information. After submitting your registration, the FDA will review your application and may contact you for additional information. It's important to note that you must renew your registration every two years to remain in compliance with FDA regulations.

What happens after fda food facility registration?

After completing the FDA food facility registration process, your facility will be assigned a unique registration number that must be displayed on all food products manufactured or processed at your facility. The FDA will also conduct routine inspections of your facility to ensure compliance with food safety regulations. If any issues are found during an inspection, the FDA may take enforcement action, such as issuing a warning letter or even shutting down your facility. It's important to maintain good communication with the FDA and stay up-to-date on any changes to food safety regulations to ensure ongoing compliance.

Food Facility Registration and Renewal

Starting or operating a food business requires registering and/or renewing with the right authorities. This process ensures your business follows local, state, and federal rules to protect consumers. Our team of experts at Quality Smart Solutions (QSS) can help you navigate the complex FDA Food Facility Registration and Renewal process. We offer guidance by providing step-by-step direction and communicate directly with FDA officials to register your food facility or renew your current registration to prevent import delays, US border detention and keep your facility in compliance. Our goal is to protect your business and ensure importing into the United State is without disruption.

Get help with FDA Food Facility Registrations and Renewals

Registering a food facility with the FDA might seem simple but can be confusing. At QSS, we provide a full range of services to help both US and foreign businesses with this process. Our experts handle the paperwork and communicate with FDA officials to make sure your registration goes smoothly.

Our services include:

DUNS Request
US Agent Appointment
Filing the Online Application with FDA through FURLS
Obtaining a FDA Establishment Identifier (FEI)
Receiving a Registration Certificate

What is FDA Food Facility Registration?

The FDA Food Facility Registration is a mandatory requirement for most food facilities that manufacture, process, pack, or store food for consumption both domestically in the United States and foreign facilities. The regulation was implemented under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (commonly called the Bioterrorism Act) and later strengthened by the Food Safety Modernization Act (FSMA) in 2011.

What Are the Requirements for Food Facility Registration?

Any facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States must register with the FDA. This includes both U.S.-based facilities and foreign facilities exporting food to the U.S. All foreign facilities (ie. outside the United States) must designate a US Agent for communication purposes. Facilities are required to renew their registration every two years during the biennial registration renewal period, which runs from October 1 to December 31 of even-numbered years.

How Can You Register a Food Facility?

Food facility registration is done electronically through the FDA’s Unified Registration and Listing System (FURLS) by logging into the FDA Industry Systems (FIS). An account must first be set up before online registration can begin. After the registration is completed and submitted FDA will review before issuing the FEI number.

What Information is Required for FDA Food Facility Registration?

The information required for FDA food facility registration includes:

Facility Information: The name, physical address, and phone number of the facility.
Parent Company Information (if applicable): The name, address, and phone number of the parent company, if the facility is owned by one.
Owner, Operator, or Agent-in-Charge Information: Contact details for the facility’s owner, operator, or agent-in-charge.
U.S. Agent (for foreign facilities): Foreign facilities must designate a U.S. agent who resides in or maintains a business in the U.S. The agent serves as a point of contact for the FDA regarding inspections and other matters.
Emergency Contact Information: Facilities are required to provide a 24-hour emergency contact number.
Type of Activity Conducted at the Facility: Facilities must disclose the type of activity they perform, such as manufacturing, processing, packing, or holding food.
Food Product Categories: Facilities must list the types of food products they handle based on FDA’s established categories.

What are the FDA Food Facility Registration Costs?

At this time FDA does not charge a fee to register food facilities.

Who must Complete a FDA Food Facility Registration?

Foreign facilities must designate a US agent for communication purposes.

Some entities are exempt, such as farms, retail food establishments (e.g., grocery stores, restaurants), non-profit food establishments, and facilities regulated exclusively by the U.S. Department of Agriculture (USDA). Some specific examples include establishments that prepare less than 200 meals per day, businesses that do not sell more than $10,000 worth of food per month, service providers related to the preparation of food.

US FDA Food Facility Registration Purpose

Any facilities that are engaged in manufacturing, packaging, processing or holding foods, beverages, or dietary supplements (that are consumed in the US) must register with the Food and Drug Administration (FDA). Any facilities located outside of the US must also register with the help of a US agent to communicate with the FDA on their behalf.

The purpose of the registration process is to ensure that food facilities comply with federal laws and regulations regarding food safety and quality. It also helps the FDA keep track of food facilities so that they can monitor compliance with these rules.

Who needs to register their food facility with the FDA?

According to the FDA, all domestic and foreign facilities that manufacture, process, pack, or hold food for consumption in the United States are required to register with the agency. This includes facilities that produce food for humans or animals, as well as facilities that store or transport food products. Some exemptions may apply, such as facilities that only handle certain types of food or that are already registered with other government agencies. It’s important to check with the FDA to determine if your facility needs to be registered.

When does the FDA food registration deadline expire?

FDA food facility registrations must be renewed on the even numbered year regardless of when the initial registration was setup For example, if an initial registration was set up in 2023 the renewal must still occur in 2024. Thereafter, the biennial renewal, in this example, would then occur in 2026, 2028 and so on.

What if the Food Facility Registration or Renewal is not filed with FDA?

If a food facility is not initially registered there are two ways that FDA can take action. For domestic sites not registered FDA can take legal action including fines, penalties. For sites based outside the United States the FDA and US Customs and Border Protection agency can detain (and detention fees paid by exporter until food facility registration information is confirmed) or issue destruction of imported products.

If facilities are not renewed in the even numbered year between October 1 and December 31 FDA will inform the registrant their FEI number is no longer valid and a new registration is required.

How do I obtain a FDA issue Food Facility Registration Certification?

FDA does not issue a food facility registration certification. They will issue an FEI number that is associated with the registered facility. There is no public database for food facility registrations to search from. However, the facility owner can A consulting company like Quality Smart Solutions can prepare a document that resembles a certificate containing all the pertinent details of the registered facility.

What happens after a facility is registered with FDA?

After completing the FDA food facility registration process, your facility will be assigned a unique registration number called a FDA Establishment Indentifier (FEI) that must be displayed on all food products manufactured or processed at your facility. The FDA may conduct inspections of your facility to ensure compliance with food safety regulations as per FSMA. If any issues are found during an inspection, the FDA may take enforcement action, such as issuing a warning letter or even shutting down your facility. It’s important to maintain good communication with the FDA and stay up-to-date on any changes to food safety regulations to ensure ongoing compliance.

How to check if a FDA Food Registration Renewal has been Rejected?

After submitting your FDA renewal application, the FDA will make a decision relatively quickly, in 3 to 5 business days. The FDA can approve or deny your application, or they may reject it. If an inspection was performed, the inspector might require changes in order for the FEI to remain valid. It’s important to check with the FDA and follow up if there is any indication of rejection, as you should also not forget any supplemental information, such as product data sheets, lab test results, or other technical documentation. Otherwise you risk missing the renewal deadline and being required to start over with a new application.

Frequently Asked Questions

What facilities need to register with the FDA?

Facilities that are engaged in manufacturing, packaging, processing, or holding foods, beverages, or dietary supplements (that are consumed in US) must register with the Food and Drug Administration (FDA). Any facilities located outside of US must also register their facilities and employ a US agent to communicate with the FDA.

How often does the FDA require facility renewal?

Food facilities must renew their FDA registration between October 1st and December 31st once every 2 years on even numbered years. All Drug, Medical Device and API facilities registered with FDA are required to renew their registration annually between October 1st and December 31st.

What will happen if your products don’t comply with the FDA requirements?

The US regulatory authority may consider your products that are not complying with FDA renewal requirements misbranded and may lead to FDA detention of your products.

Who can submit a Food Facility Renewal application?

The owner, agent, operator in charge of the establishment or a person authorized by one of them has the right to submit an application for registration or renewal of the facility electronically on the FDA website. It is important to note that you must have a FURLS account, or you need to create one for accessing the module and for submitting your renewal.

What is needed to file a Food Facility Registration or Renewal?

DUNS Number
Filling Online Application
US Agent Appointment Authorization
Submission of Application for FDA Registration
Getting an 11 Digit Food Facility Registration Number from the FDA

Receipt of Registration Certificate from US Agent