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Home โ€บ US FDA Services โ€บ Food Facility Registration
๐Ÿฝ๏ธ US FDA ยท Food Facility Registration

FDA Food Facility Registration

What is US FDA Food Facility Registration?

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), effective on December 12, 2003, directs the FDA โ€” as the food regulatory agency for the Department of Health and Human Services โ€” to protect public health from any terrorist attack and other food-related threats to the public.

The FDA Food Safety Modernization Act (FSMA) requires food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA.

Registration and renewal of US FDA food facility registration are required every other year (biennially) under the current law. IAS offers an all-inclusive package for new or renewal US FDA registrations.

Steps in FDA Food Registration

Step 1: Register Your Facility (DUNS)

Organizations need to register their facility with the US FDA and must have a 9-digit DUNS Number. (Currently, the FDA recognizes foreign companies โ€” those outside the US โ€” through the DUNS Number only.)

Step 2: Submit Documents

Send us the required documents for US FDA registration through email or fax.

Step 3: Payment

Payment via secure credit card transaction or wire transfer.

Step 4: Paperwork Prepared

We provide you with all the necessary paperwork to send to the US FDA within 24 hours after receiving payment.

Step 5: Application Monitoring

We monitor your US FDA registration application status for the duration of the process.

Fees for US FDA Food Facility Registration

  • Food facility registration fee for new applicants: US$585.
  • US FDA renewal and update of existing registration: US$485.
  • US Agent fee (annual): US$350.

About the DUNS Number

The Dun & Bradstreet Number (DUNS) is a non-financial identification number, subject to certain conditions and registered with official institutions. The DUNS Number is required by the US FDA for all food-related businesses that want to apply for US FDA Food Facility Registration.

To receive your DUNS Number, you have to complete the Data Universal Number System (DUNS) mandatory requirements. IAS can arrange the DUNS Number based on the client's request. It may take up to 90 days for the free version of the DUNS Number to be received from dnb.com; a paid option is available to receive it more quickly.

Why Choose IAS for Food Facility Registration

Integrated Assessment Services (IAS) is a global services provider with experience helping food facilities and their supply chains worldwide with US FDA Food Facility Registration. Our team has helped more than 2,000 clients worldwide with their US FDA-compliant registration, easing the way for entering the US market.

With over 2,000 satisfied customers, we provide efficient yet comprehensive services to assist food establishments in the US FDA registration process. Our experienced team manages the entire process end-to-end to make your FDA Food Facility Registration smooth and hassle-free. Contact us today!

Food Facility Registration โ€” Frequently Asked Questions

What is FDA food facility registration?
Facilities (domestic and foreign) that manufacture, process, pack, or store food for US consumption must register with the FDA under FSMA.
Who needs to register?
Food facilities selling to the US market, both domestic and foreign.
How often must it be renewed?
Every two years, between Oct 1 and Dec 31 of even-numbered years.
Do foreign food facilities need a US Agent?
Yes โ€” they must designate a US Agent as their FDA contact.
Why is a DUNS number required?
FDA food facility registration requires a DUNS number to verify the facility's identity and location.
Is registration the same as FDA approval?
No โ€” it authorizes you to market; the FDA does not approve or certify food products.

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