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
fda food facility registration
What is Food Facility Registration?

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.

What are the Food Facility Registration Requirements?
Food Facility Registration

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.

FDA Food Facility
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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

FDA Food Facility Registration Exemptions

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.

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.

FDA Food Registration Deadline
FDA food facility registration renewal

Application Submission

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.

US Facility FDA Food Registration Renewal

Renewing your FDA registration can be an intimidating process, but with a few simple steps, you can make sure you’re up to date and in compliance. Learn about the application process and what paperwork is required for FDA registration renewal here. 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. 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.

fda food facility registration
FDA Registration Renewal

FDA Food Registration Renewal Submitting your Application

The first step of the renewal process is to submit a renewal application. This application can be completed online and will include the details of your facility, contact information, and so forth. Once you have created an account with the FDA and filled out all applicable fields in the renewal application, you’ll be ready to move on to the next step.

Provide 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.

FDA Food Registration Renewal
FDA Food Application Renewal

Prepare Your Filing Documentation

Carefully review the registration renewal requirements and double-check your filing documents to make sure everything is accurate. The FDA requires that you submit all necessary documents at the time of filing, so it’s important to make sure nothing is missing. You should also not forget any supplemental information, such as product data sheets, lab test results, or other technical documentation. Taking the time to prepare your filing documentation correctly can help ensure a smooth approval process.

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.

FDA Food Registration Renewal Licensing Application

Frequently Asked Questions

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.

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.

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.

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.

  • 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

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