U.S. FDA Food Facility Registration Renewal:   Critical Steps to Avoid Disruptions & Penalties

The U.S. Food and Drug Administration (FDA) requires all food facilities that manufacture, process, pack, or store food for U.S. consumption to renew their registrations every two years during the biennial registration renewal period(October 1 to December 31 of even-numbered years). Whether a facility registered years ago or just prior to the renewal period, all are subject to this requirement.

Failure to renew on time can lead to significant consequences, from operational disruptions to legal and financial penalties. In this article, we’ll explore the critical importance of properly renewing your FDA registration, highlight the pitfalls of non-compliance, and offer actionable advice to assure that your facility remains compliant.

What is FDA Registration Renewal?

Under the Food Safety Modernization Act (FSMA), facilities involved in manufacturing, processing, packing, or storing food for U.S. consumption must register with the FDA. This registration is not permanent and must be renewed every two years during the designated biennial registration period.

Importantly:

• The timing of your initial registration is irrelevant to the renewal deadline. For example, a facility that registers on September 30th of a renewal year must still renew between October 1 and December 31 of that same year.
• If a facility fails to renew, the registration is deemed “expired,” and the facility must re-register and obtain a new registration number before resuming operations.

Distributing food in the United States with an expired registration is prohibited and may result in detention of shipments at U.S. ports of entry or even civil and criminal penalties.

What Happens If You Miss the Renewal Deadline?

Missing the renewal deadline can have far-reaching consequences. In a stark example from 2019, the FDA removed 47,635 food facilities from its database after the December 2018 renewal period, resulting in over a 20% decrease in registrations. These removals occurred because facilities failed to renew their registrations on time.

Facilities with expired registrations are:

• Removed from the FDA’s Registration database
• Prohibited from manufacturing, processing, packing, or storing food for U.S. consumption until they re-register
• At risk of product detentions or refusals at U.S. ports of entry

Many facilities only realize their registration has lapsed when their shipments are detained, leading to costly delays and logistical challenges. To avoid these scenarios, proactive renewal is essential.

Consequences of Non-Compliance

Non-compliance with FDA registration renewal requirements can result in a range of penalties and disruptions:

1. Export Risks: Facilities that fail to renew may face detentions or refusals of goods at U.S. ports. Exporters may find themselves unable to access the U.S. market until their registration is restored.
2. Operational Interruptions: Domestic facilities with expired registrations cannot legally produce food for U.S. consumption, halting operations until re-registration is completed.
3. Financial and Legal Penalties: Facilities operating without valid registrations risk civil fines and, in severe cases, criminal penalties.
4. Reputation Damage: Detentions, delays, and compliance issues can damage relationships with supply chain partners, customers, and regulators.

Key Requirements for a Successful Renewal

To assure

your registration is renewed without issues, facilities must adhere to the following key requirements:

1. U.S. Agent Designation for Non-U.S. Facilities

Facilities outside of the United States are required to designate a U.S. Agent who acts as the facility’s point of contact with the FDA. Importantly, the FDA will not finalize a facility’s renewal until the designated U.S. Agent accepts the role. Selecting a reliable U.S. Agent who is prepared to act promptly is critical to avoiding delays.

2. Unique Facility Identifier (UFI) Submission

All facilities—domestic and foreign—must provide a Unique Facility Identifier (UFI), such as a D-U-N-S® number, during the renewal process. Facilities without a UFI should request one well in advance, as delays in obtaining a UFI can jeopardize timely renewal. During renewal periods, the high volume of requests can result in backlogs, so early action is essential.

3. Accurate and Updated Information

Assure all information submitted during the renewal is accurate and up-to-date. This includes facility addresses, contact details, and other essential data. Errors or outdated information can lead to processing delays or rejection.

Lessons Learned: Removal from FDA’s Registration database

The FDA’s removal of 47,635 food facilities from its database in 2019 highlights the critical importance of timely renewal. This mass removal affected over 20% of facilities in the FDA’s system. Many of these facilities failed to realize their registrations had expired until their shipments were detained or refused.

This event underscores the need for:

• Proactive planning and awareness of renewal deadlines
• Thorough verification that the renewal process was completed successfully
• Immediate corrective action if a registration lapses

Steps to Assure Compliance

1. Start Early: Begin the renewal process as soon as the registration period opens (October 1). This provides time to address any issues, such as obtaining a UFI or resolving U.S. Agent designations.
2. Verify UFI Readiness: Confirm that your facility has an active and valid UFI well in advance of the renewal period.
3. Work with a Reliable U.S. Agent: For Non-U.S. facilities, assure your designated U.S. Agent is prepared to accept their role promptly.
4. Maintain Records: Keep detailed records of your renewal submission and any correspondence with the FDA to confirm successful completion.
5. Stay Updated: Monitor FDA guidance and requirements to stay ahead of any changes that may impact the renewal process.

Protect Your Facility and Supply Chain

FDA registration renewal is a straightforward yet critical process for ensuring uninterrupted operations in the U.S. market. By prioritizing timely renewal and meeting all requirements, facilities can avoid costly disruptions, protect their supply chains, and maintain compliance with FDA regulations.

Don’t let missed deadlines or compliance oversights jeopardize your business. Registrar Corp simplifies the process with comprehensive FDA registration and U.S. Agent services. Our experienced team assures that your registration is accurate, timely, and meets all FDA requirements, giving you peace of mind and allowing you to focus on your operations.

Use our free Registration Verification Tool to and see if your registration is still valid.