Food Facility Registration and Renewal

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.

US FDA Food Facility Registration

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

US FDA 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. 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 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.

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

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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