A businessman discovers how simple it is to obtain an FDA food facility registration number through Registrar Corp.
Author

Fabiola Negron

Director of Food Safety

How to Obtain Your FDA Food Facility Registration Number

Nov 7, 2023

The Food & Drug Administration (FDA) requires that all food and beverage facilities register and then renew their FDA food facility number biennially. This is to help prevent food supply-related attacks, hazards, threats, and emergencies as mandated by the Bioterrorism Act and the Food Safety Modernization Act (FSMA). 

Among other regulations, facilities must register with FDA before shipping to the U.S. to assure compliance, keep their products out of detention, and to avoid demurrage fees. Renewal of an FDA food facility number is required every even-numbered year between October 1 and December 31. 

Understanding Food Facility Registration 

Your FDA food facility registration number is a critical requirement for your business to market and sell its products in the U.S. The U.S. FDA assigns a unique registration number to each registered food facility to: 

  • Facilitate communication between FDA and a foreign facility for routine and emergency communication  
  • Allow FDA to plan food facility inspections  

FFR numbers can also help FDA track your facilities’ activities when investigating the origin of a public safety event.

It’s also important to keep in mind that the assignment of the FDA registration number does not imply the approval of your establishment or product by the U.S. FDA. Instead, the FDA registration number only recognizes that your establishment is registered with the U.S. FDA. 

Obtaining a Food Facility Registration Number 

Regardless of whether your facility is located internationally or in the United States, FDA requires all facilities that manufacture, process, pack, or hold food and beverages for distribution in the United States to both register and renew.  

When applying for a food facility registration number there are several pieces of information you should have on hand: 

  • A Unique Facility Identifier number; a 9-digit DUNS number 
  • Facility name & address information 
  • Parent company name & address information if applicable 
  • Facility emergency contact information 
  • Any trade names used 
  • U.S. Agent who has accepted this designation if the facility is internationally located 
  • General product categories and the type of activity conducted at the facility 
  • Information regarding the Owner, Operator, or Agent in Charge 

After the U.S. Agent has accepted their designation and once this information is submitted, reviewed, and accepted by FDA, you will then be given an 11-digit food facility registration number and are one step closer to distributing products throughout the United States.  

Significance of Food Facility Registration Numbers 

Registration of your facility helps provide transparency in the global supply chain. FDA is able to use this number to locate and track the source of any threats to public safety — such as any harmful contamination of the products — to prevent further spread or recurrence of harmful food safety issues. 

Obtaining registration also opens the entire U.S. market to your business, allowing your products to reach 160-million consumers with disposable income. 

Ignoring registration not only bars your products’ entry to the United States, but any attempt at exporting to the U.S. may land your product in detention or force legal and federal action against your business.  

Maintaining Food Facility Registration 

It’s important to understand that once registration is accepted by FDA and you have been given your food facility registration number, you will be required to update FDA regarding any changes to your registration and to renew every 2 years. 

Updating FDA Registration 

A facility’s registration must be updated within 60 calendar days of any changes to the information originally submitted during registration except in the case of ownership changes. Examples of when to update include (but are not limited to): 

  • Relocation of facility 
  • A change of operator 
  • New agent in charge 
  • Change of U.S. Agent 
  • Any changes to your DUNS information 

FDA has technically required all Food Facilities to report a DUNS Number since 2020, but did not start enforcing this requirement until March 2023. FDA is now routinely reviewing its records and canceling registrations where the agency finds the DUNS an unacceptable representation of the FFR data.   

That means a registration number that was valid last month could be cancelled this month, and you don’t want to find that out when you have a shipment on the water. Failure to update in a timely manner may also earn a suspension or even cancelation of your food facility registration number.   

Renewing FDA Registration 

FDA requires all facility registrations to be renewed every even-numbered year between October 1 and December 31. 

Failing to renew will result in FDA treating your registration number as expired and will then cancel your registration. This will immediately place moving shipments — and your bottom line — at risk. Not only can your products be refused entry, they can be seized and placed in detention, accrue demurrage fees, they can be destroyed on site, or simply risk spoilage if held for too long.  

Verifying FDA Registration 

The FDA may invalidate a facility’s registration for a number of reasons, from lack of current information to missing renewal deadlines. Without a correct and complete registration, your company could face serious fees, fines, or shipment detentions and delays. If you have any question about the status of your registration, you should seek verification. 

Registrar Corp offers U.S. FDA registration verification at no cost so that suppliers can quickly determine whether their registrations are valid and in compliance with FDA’s requirements. 

How to Simplify FDA Registration 

Assuring you have the correct documents on hand for your specific needs and submitting accurate information to FDA can be challenging for many businesses. Staying on top of updates and renewals can pose an equal challenge when business operations, personnel, and pushing the initiatives that matter most demand your attention. 

Registrar Corp makes FDA Registration quick and easy. 

We’ve spent the last two decades helping over 30,000 companies each year across 190+ countries understand the complexities of U.S. FDA regulations. From food facility registration numbers to meeting all FSVP & FSMA requirements, we know how to help you navigate and achieve compliance.  

Register your food facility with FDA the right way. 

Author


Fabiola Negron

Director of Food Safety

Widely respected in the Food Safety industry, Fabiola provides insightful education to food and beverage companies worldwide on U.S. FDA regulations resulting from the passage of the Food Safety Modernization Act (FSMA) in 2011. Her expertise in creating and reviewing Food Safety plans, helping U.S. importers comply with Foreign Supplier Verification Program (FSVP) regulations, and leading our Food Safety team have helped hundreds of companies comply with FDA food and beverage requirements.

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