The U.S. Federal Food and Drug Administration is requiring all non-exempt food facilities, whether foreign or domestic, to register or renew their facilities by December 31, 2022, or their registrations will expire. ASC Software has compiled the following information snippets to help food manufacturers, suppliers, and warehouses to meet the FDA food facility registration deadline and remain compliant.
Why is food facility registration important?
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, later amended by the FDA Food Safety Modernization Act (FMSA) in 2011, requires food facility registration and renewals every other year for food safety purposes. Registration provides critical information to the FDA to help identify the location and possible source of food-borne illness outbreaks or possible bioterrorism occurrences, should they arise. Food facilities that do not register by the deadline will have their imports denied entry into the U.S. and domestic exports will be denied.
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Who must register or renew with the FDA?
According to the FDA, owners, operators, or agents in charge of a domestic or foreign facility engaged in the manufacture/processing, packing, or holding of food for human or animal consumption in the U.S., are required to register their facility.
How do I renew my FDA registration?
Per recently updated FDA requirements most food manufacturing companies and warehouses must complete their registration renewal online through the FDA’s portal. An FDA Industry System (FIS) account is required to access program resources.
What information does the FDA require?
According to an article by international law firm Harris Bricken, all renewing food facilities are required to furnish a Unique Facility Identifier (UFI). The only facility identifier the FDA recognizes in this connection is the Data Universal Numbering System or DUNS number that is specifically assigned and managed by Dun and Bradstreet. A DUNS number associated with the PHYSICAL location of the food facility MUST be provided during renewal and the FDA will no longer offer flexibility. You can retrieve your DUNS number through the D&B Import Safety Lookup Portal.
The FDA requires that the name and contact information on the food facility registration must EXACTLY match the DUNS number contact information. The two must be an exact match to every character, otherwise, the FDA registration will be rejected.
Related: Understanding Food Traceability Requirements for Retailers
Where can I get more information about FDA food facility registration?
Interested food warehouses and manufacturers can find more information about registration renewal from the FDA’s Food Facility Registration User Guide: Step-by-Step Instructions for Registration page.
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Common Mistakes That Delay FDA Registration Renewal Processing
Understanding frequent errors in online FDA registration facility renewal submissions can save valuable time and prevent last-minute compliance issues. The FDA reports that approximately 30% of renewal applications require additional review due to preventable mistakes.
The most critical errors include:
- DUNS number mismatches: Contact information that doesn’t exactly match D&B records character-for-character, including punctuation and spacing
- Incomplete facility descriptions: Vague or outdated descriptions of food processing, packing, or holding activities
- Missing emergency contact information: Failure to provide 24-hour contact details for facility representatives
- Incorrect facility classification codes: Selecting wrong food category codes that don’t accurately reflect current operations
Facilities should verify their DUNS information through the D&B Import Safety Lookup Portal at least 30 days before beginning the fda registration renewal process. This allows time to correct any discrepancies with Dun and Bradstreet before submission deadlines approach.
Timeline Planning for Successful FDA Facility Registration Renewal
Strategic timeline management ensures compliance with fda food facility registration renewal frequency requirements while avoiding operational disruptions. The FDA processes renewals on a rolling basis, but facilities that wait until the final weeks often face delays.
Recommended 60-Day Renewal Schedule
Food facilities should follow this proven timeline for us fda food registration renewal success:
- 60 days before expiration: Verify current DUNS number accuracy and gather required documentation
- 45 days before expiration: Create or update FDA Industry System (FIS) account credentials
- 30 days before expiration: Submit renewal application through the FDA portal
- 15 days before expiration: Follow up on application status and address any FDA requests
Facilities with complex operations or multiple locations should begin the process 90 days in advance. This extended timeline accommodates potential DUNS updates, which can take 2-3 weeks to process, and allows sufficient time for FDA review of detailed facility information.
Early submission also provides a buffer for addressing unexpected issues without jeopardizing import/export operations that depend on valid registration status.
Frequently Asked Questions
What is FDA food facility registration?
FDA food facility registration requires domestic and foreign facilities that manufacture, process, pack, or hold food for consumption in the United States to register with FDA. Registration enables FDA to identify and locate facilities in emergencies. The requirement applies to most food operations with limited exemptions.
When must food facilities renew registration?
Food facilities must renew registration during the biennial renewal period, which runs from October 1 to December 31 of even-numbered years. Failure to renew by the deadline suspends registration, potentially preventing food from being legally sold or imported into the United States.
What information is required for FDA registration?
Registration requires facility name and address, emergency contact information, product categories handled, and US agent information for foreign facilities. Facilities must update registration within 60 days of any changes. The registration process is free and completed through FDA electronic system.
What happens if a facility fails to register or renew?
Unregistered facilities cannot legally offer food for import or domestic commerce in the United States. FDA can hold or refuse food from unregistered facilities. Penalties for operating without registration can include warning letters, seizures, and criminal prosecution for serious violations.
How can facilities ensure successful registration renewal?
Success requires tracking renewal deadlines, verifying current registration information accuracy, updating any changes before the renewal period, and completing renewal promptly rather than waiting until the deadline. Designate responsibility for registration compliance and maintain FDA account credentials securely.
