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.

Food Facility Registration and Renewal

Setting up a food business or facility is a complex process that involves registering with the proper authorities, including local, state and federal regulations. This guide provides an overview of the necessary steps involved in registering a food facility or business.

Our team of US compliance experts can help with your FDA Food Facility Registration or Renewal. We help by providing step-by-step guidance and communicate with FDA officials to register your food facility or renew your current registration to avoid any late fees.

Get help with FDA Food Facility Registrations and Renewals

Registering a food facility with the FDA seems to be simple, but it can sometimes be a confusing and lengthy process. At Quality Smart Solutions, we are committed to offering a full range of FDA Food Facility Registration/Renewal consulting services to domestic and foreign establishments. Our US compliance experts will also provide guidance with regards to paperwork and qualifications to move you quickly and efficiently through the registration or renewal process.

DUNS Request
Filing Online Application
US Agent Appointment Authorization
Submission of Application for FDA Registration
Obtaining a Food Facility Registration Number
Receipt of Registration Certificate from US Agent

What is Food Facility Registration?

Food facility registration is the process of submitting an application to a government authority in order to obtain approval for the establishment, modification or operation of a food business. This registration is necessary in order to comply with safety and health regulations and ensure that the foods produced by the facility are safe for consumption. It’s also important to register in order to protect consumers from potentially harmful contaminants and pathogens.

What Are the Requirements for Food Facility Registration?

The deadline for submitting a registration application is generally one year after the date of opening. However, there are some exceptions. If a facility has been open less than six months, then the deadline is three months after the date of opening; if a facility has been open more than five years, then the deadline is five years after the date of opening, etc.

How Can You Register a Food Facility?

Registering a food facility typically requires submitting an application and other required documentation to the governing authority in your country. Depending on the area, you may be able to file electronically or in person. In some cases, you may need to obtain specific permits prior to being allowed to operate the facility, or meet certain public health requirements related to hygiene, storage, or production processes.

What Type of Food Facility Registration Compliance is Required by Law?

Food facility registration requirements vary between countries and jurisdictions, but there are a few basics that are typically required. Generally speaking, you will be required to provide basic information about the facility, such as its location and type of ownership as well as information about any products manufactured or served at the facility. Additionally, food manufacturers must comply with requirements regarding proper labeling and quality control measures. Registration authorities may also require food facilities to register their facility with their appropriate governing authority in order to remain compliant with the law.

What are the FDA Food Facility Registration Costs?

There are two main ways to pay for registration: by using an electronic payment system or by paying cash. Electronic payments are typically made through credit cards or debit cards. Cash payments are usually made in person at the FDA office.

Who must complete FDA Food Facility Registration?

All FDA food facilities must register with the FDA unless they meet one of the exemptions listed below.

Exemption 1: Establishments that prepare less than 200 meals per day

Exemption 2: Establishments that do not sell more than $10,000 worth of food per month

Exemption 3: Establishments that only prepare food for immediate consumption

Exemption 4: Establishments that serve food to customers who purchase the food at the facility

Exemption 5: Establishments that provide services 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.

When does the FDA food registration deadline expire?

Once registered, you must maintain your food facility registration to stay in good standing. This includes monitoring and recording changes to the business, such as changes in ownership or location, providing annual product sales information, and submitting relevant documentation for any modifications made to the facility or products produced there. Depending on the governing authority, you may also need to renew your food facility registration each year.

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.

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.

How to provide food facility compliance certifications?

After your application is complete, you must provide compliance certifications for each product or facility you are registering. For product registration, the FDA requires manufacturers to verify that their products meet or exceed all applicable safety and efficacy standards. For facility registration, manufacturers must show evidence that the facilities meet all necessary regulations and requirements. You must submit the appropriate documentation and paperwork in order to be approved for renewal.

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.

How to check for FDA Food Registration Renewal Rejection?

After submitting your FDA renewal application, the FDA will make a decision within 120 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 registration to be accepted. 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. 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