Registering your food facility with the U.S. Food and Drug Administration (FDA) is mandatory for all facilities that manufacture, process, pack, or hold food (for both humans and animals) and dietary supplements for consumption in the United States. This registration helps the FDA track and trace food in case of a food safety incident. This article GOL will guide you on how to obtain and search for your FDA food facility registration number.

What is the FDA Food Facility Registration Number

The FDA Food Facility Registration is a mandatory process for facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States. It is required by the Bioterrorism Act of 2002 and implemented by the Food and Drug Administration (FDA).

Getting your FDA food facility registration number is an essential step to legally selling your products in the United States. This unique identifier serves several crucial purposes:

1. Streamlined communication: It acts as a bridge for the FDA to easily communicate with your facility, both for routine inquiries and urgent situations.
2. Targeted inspections: The FDA uses your registration number to schedule and prioritize inspections, ensuring food safety standards are upheld.
3. Enhanced traceability: In case of a public health concern, your number helps the FDA quickly track your facility’s involvement and activities.

Important to remember: Having a registration number doesn’t imply FDA approval of your facility or products. It simply confirms that you’re registered and subject to their regulations.

Read more: FDA approved vs FDA cleared: The differences you need to know

How to obtain a Food Facility Registration Number

Who Needs to Register?

Whether you’re a bustling international manufacturer or a local farmer’s market vendor, the FDA requires registration for all facilities involved in:

• Manufacturing food and beverages
• Processing ingredients into edible products
• Packing food for distribution
• Holding food for later sale

Remember, this applies to both domestic and international facilities supplying the US market.

What Do You Need?

Before diving in, gather these essential details:

• Unique Facility Identifier (UFI) number: This unique code identifies your facility.
• 9-digit DUNS number: This Dun & Bradstreet number helps track business information.
• Facility information: Name, address, and emergency contact details.
• Parent company details (if applicable): Name and address.
• Trade names: Any alternative names your facility operates under.
• U.S. Agent (for international facilities): Contact information of a designated representative in the US.
• Product categories: Identify the types of food and beverages you handle.
• Activity details: Specify the specific actions you perform (e.g., baking, freezing, packaging).
• Owner/Operator/Agent in Charge: Information about the responsible individual.

The Registration Process

1. Gather your documents: Make sure you have all the required information readily available.
2. Head to the FDA website: Access the Food Facility Registration module through the FDA Industry Systems (FIS) platform.
3. Create an account: If you haven’t already, register for an FIS account.
4. Fill out the application: Carefully enter your prepared information into the online form.
5. Review and submit: Double-check your entries and submit the application for review.
6. Wait for approval: The FDA will process your application, typically within 30 days.
7. Receive your number: Upon approval, you’ll receive your unique 11-digit Food Facility Registration Number.

Some note

• Renewal is mandatory: Your registration expires every two years, so renewing is crucial for continued compliance.
• Registration doesn’t imply approval: Having a number doesn’t mean the FDA endorses your facility or products. It simply confirms your registration and compliance obligation.

Importance of Food Facility Registration Numbers

Food facility registration numbers are far more than just a bureaucratic hurdle. They unlock crucial benefits for both businesses and consumers, acting as:

A Shield for Public Safety:

• Enhanced Traceability: Each registration number acts as a unique identifier, allowing the FDA to quickly track and locate the source of any potential food safety threats, such as harmful contamination. This swift tracing prevents the spread of foodborne illnesses and ensures timely interventions.
• Transparency in the Supply Chain: Registration numbers increase transparency within the global food supply chain. The FDA can access and share information about registered facilities, fostering trust and collaboration among stakeholders.

A Gateway to the US Market:

• Unlocking 160 Million Consumers: Obtaining a registration number unlocks the vast US market, granting access to over 160 million consumers with significant disposable income. This opens doors to tremendous business growth and expansion potential.
• Compliance, Not just Convenience: While access to the US market is certainly attractive, registration is not merely optional. It’s a mandatory requirement for any facility aiming to export food to the US. Ignoring this mandate can result in:
  • Product Detention: Your products could be detained at the border, delaying or even preventing entry into the US market.
  • Legal and Federal Action: Non-compliance can lead to legal action and penalties, potentially impacting your business reputation and future endeavors.

In essence, food facility registration numbers are not just administrative burdens, but strategic tools that safeguard public health, open doors to massive markets, and ensure compliance. By obtaining and maintaining your registration, you contribute to a safer food system and unlock exciting opportunities for your business to thrive in the US market.

Updating FDA Registration

It is imperative to keep your facility’s FDA registration current by promptly updating any changes to the information initially provided during registration, with a deadline of 60 calendar days for most updates, except for ownership changes. Instances that necessitate updates include, but are not limited to:

• Relocation of the facility
• Change in operator
• Appointment of a new agent in charge
• Alteration of the U.S. Agent
• Modifications to DUNS information

While the FDA technically mandated the reporting of a DUNS Number for all Food Facilities from 2020, enforcement of this requirement only commenced in March 2023. Presently, the FDA actively reviews its records and may cancel registrations if the DUNS is deemed inadequate to represent the FFR data accurately.

This implies that a registration number deemed valid in the previous month could be subject to cancellation in the current month. Discovering such a cancellation when your shipment is already in transit can lead to significant complications. Moreover, failure to update your registration in a timely manner may result in suspension or even cancellation of your food facility registration number. Therefore, ensuring timely updates is crucial to maintain compliance and avoid disruptions in your business operations.

The Importance of Timely FDA Registration Renewal

Every two years, a critical deadline looms for food facilities: FDA registration renewal. Missing this window between October 1 and December 31 of even-numbered years can have serious consequences for your business.

Here’s what’s at stake:

• Expired Registration, Closed Doors: If your registration isn’t renewed, the FDA considers it invalid. This means your shipments are barred from entering the US, effectively shutting down your access to a massive market.
• Financial Fallout: Products caught in limbo at the border can face a harsh reality:
  • Seizure and Detention: Your goods might be confiscated and held, incurring storage fees that quickly escalate.
  • Destruction: If held too long, your products could be deemed unsafe and destroyed, resulting in a complete loss.
  • Spoilage: Delays due to detention can lead to spoilage, wasting valuable inventory and further impacting your bottom line.

Renewing your registration is not just a formality, it’s a necessity for:

• Business Continuity: Ensures your products can seamlessly flow into the US market, avoiding costly disruptions and potential losses.
• Peace of Mind: Knowing your registration is current allows you to focus on growing your business, not worrying about compliance issues.

Don’t wait until the last minute! Start your renewal process well in advance to avoid any potential complications. The FDA provides clear instructions and resources to make the process smooth and efficient.

Confirming FDA Registration

FDA may revoke a facility’s registration due to various reasons, ranging from outdated information to failure to meet renewal deadlines. A flawed or incomplete registration puts your company at risk of substantial fees, penalties, or disruptions in shipment processes. If you have any uncertainties regarding the status of your registration, it’s crucial to seek verification promptly.

How to search FDA registration number?

Searching for a food facility registration number online can be challenging due to the absence of a publicly available database. However, if you are the owner of the facility, you can reach out to the FDA to obtain your registration details. Should you require assistance with locating your FDA registration number, please don’t hesitate to contact us, and we will offer you detailed guidance, free of charge.

Searching for FDA Registration Numbers is a common query among manufacturers registered with the US FDA. They often inquire about:

• How to locate their registration number on the FDA website?
• How can their customers search for their FDA Registration Number?
• How to confirm if the FDA registration process is complete?
• Whether the FDA issues a Registration Certificate with the FDA registration number?

FDA requirements vary for each type of registration. For food facilities, obtaining the FDA registration number is obligatory, and it is typically received immediately upon completion of the registration process. However, for drug and medical device establishments, while registration is mandatory, the assignment of an FDA registration number is not. It may take 90 days or more for the FDA to assign registration numbers to drug and medical device establishments. Additionally, FDA does not provide a Registration Certificate upon completing registrations for food, drugs, medical devices, cosmetics, or blood establishments.

The table below offers direct links to the FDA search page and specifies the correct terms to use for conducting an FDA registration number search.

Finding Clarity and Efficiency in Food Facility Registration

Navigating the complexities of FDA Food Facility Registration can feel like a daunting task, especially for busy businesses juggling multiple demands. Keeping track of diverse documents, ensuring accuracy, and remembering renewal deadlines can easily slip through the cracks.

When it comes to FDA registration services, that’s where GOL comes in. We recognize the obstacles you encounter and provide an extensive array of services to streamline your FDA registration process:

• Document Expertise: Our team of experienced professionals guides you through the specific document requirements based on your unique business needs, ensuring you have everything necessary for a smooth application.
• Data Accuracy Guarantee: We meticulously review and verify all submitted information, minimizing the risk of errors that could delay your registration or lead to future complications.
• Renewal Reminders & Management: We take the burden off your shoulders by proactively reminding you of upcoming renewal deadlines and handling the entire process for you, ensuring uninterrupted compliance.
• Ongoing Support: We’re here to answer any questions you may have throughout the process, providing ongoing support and guidance for your peace of mind.

Don’t let FDA registration be a barrier to your success. Let GOL simplify the process and empower you to focus on what matters most – growing your business.

Contact us today to learn more about how we can help you achieve smooth and efficient FDA Food Facility Registration.

References: 

According to An official website of the United States government – U.S. Food & Drug Administration (FDA) – Drugs@FDA: FDA-Approved Drugs 

According to An official website of the United States government – U.S. Food & Drug Administration (FDA) – Drug Approvals and Databases