What Is the FDA Food Facility Registration Process?

 

If your company manufactures, processes, packs, or stores food for consumption in the United States, you are required by law to register your facility with the U.S. Food and Drug Administration (FDA). This applies to both domestic and foreign facilities and is a critical step for legally entering the U.S. food market.

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Who Must Register?

Under the Bioterrorism Act of 2002 and updated requirements from the Food Safety Modernization Act (FSMA), the following types of businesses must register their food facilities with the FDA:

• U.S. food manufacturers, processors, packers, or storage warehouses

• Foreign food facilities that export to the U.S.

• Facilities dealing with dietary supplements, food ingredients, or pet food

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If you are a foreign food facility, you must also appoint a U.S. FDA Agent as your official contact point.

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Step-by-Step: FDA Food Facility Registration Process

 

Step 1: Create a FDA Industry Account

Register through the FDA Industry Systems (FIS) portal. This is where all food facility registration and management takes place.

 

Step 2: Gather Required Information

Before submitting your registration, prepare the following:

• Facility name and address (physical location)

• Contact information for the owner or operator

• Product categories handled at the facility

• Emergency contact details

• U.S. Agent information (for foreign facilities only)

 

Step 3: Submit the Initial Registration (Form 3537)

The registration is completed online through the FDA portal using Form 3537. There is no fee for registration.

 

Step 4: U.S. Agent Confirmation (for Foreign Facilities)

For foreign food facilities, the designated U.S. FDA Agent must confirm the appointment via email. This step is required before registration becomes effective.

 

Step 5: Receive FDA Registration Number

Once approved, the FDA will issue an 11-digit registration number. This number must be used for customs clearance and Prior Notice submissions.

 

Step 6: Renew Every Two Years (Biennial Renewal)

FDA food facility registration must be renewed between October 1 and December 31 of each even-numbered year (e.g., 2024, 2026). Failure to renew may result in cancellation.

 

Why Is FDA Registration Important?

• Required for U.S. import clearance

• Enables Prior Notice submission

• Prevents shipment delays and rejections at customs

• Shows commitment to U.S. food safety standards

 

Need Help Registering Your Facility?

At Willow Glen Consultancy LLC, we simplify the FDA food facility registration process for both U.S. and international companies. Our services include:

• Preparing and submitting Form 3537

• Acting as your U.S. FDA Agent

• Handling biennial renewals and updates

• Consulting on FSMA and FSVP compliance

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