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FDA Enters a New Phase of UFI Enforcement: Is the Food Industry Ready?

Oct 17, 2023

The U.S. Food and Drug Administration (FDA) requires that all food facilities, both U.S. and non-U.S., provide a “Unique Facility Identifier (UFI) recognized as acceptable by FDA.” This UFI should contain a facility name and physical address that correspond with FDA’s database and Dun & Bradstreet’s Data Universal Numbering System (DUNS) database. Failure to comply will result in various potential penalties under UFI Enforcement.

At this time, FDA only recognizes the DUNS number as an acceptable UFI. See question and answer F.2.3 at FDA’s Seventh Edition Guidance for Industry.)  

While this rule went into effect on October 1, 2020, FDA exercised enforcement discretion until March of 2023 when they canceled thousands of Food Facility Registrations for failure to produce an “acceptable” DUNS number. Beginning on September 15, 2023, FDA has entered a new and unprecedented phase of UFI enforcement for facilities that manufacture, process, pack, or hold food intended for consumption in the United States.  

If your food facility has recently received an email from FDA with the subject line, “Pending Unique Facility Identifier,” or “Unique Facility Identifier Verification,” then your compliance countdown has begun! Read on to learn how FDA’s new UFI enforcement could affect you as an importer, exporter, or FDA-registered facility.  

U.S. Food Facility Importers 

FDA has required U.S. owners or consignees (or FSVP Importers) of food offered for import to identify themselves with a DUNS number in their customs entries since July 24, 2022But did you know that FDA now requires a DUNS number to verify the existence and operations of your suppliers, too?  

If you are a U.S.-based importer of food, beverages, or dietary supplements, you may want to verify that they’ve been assigned a DUNS number where the name and address listed in the DUNS record correspond to the information registered with FDA.  

As of September 15, 2023, FDA will no longer issue an 11-digit Food Facility Registration number until the DUNS number has been verified by FDA. This means you need to verify suppliers’  registration and DUNS information before any cargo is shipped to avoid lengthy and costly delays.   

Verify your suppliers’ FDA Food Facility Registration and DUNS numbers. 

Non-U.S. First-Time Exporter Facilities 

If you own or operate a food facility outside of the U.S. that manufactures, processes, packs, or holds food intended for consumption within the United States, be aware that FDA’s food facility registration process has changed.  

As of September 15, 2023, FDA will not assign a food facility registration number until they have reviewed and accepted the corresponding DUNS number. DUNS number assignment can take up to 30 business days, and FDA’s review process takes additional time, so it’s important to obtain your DUNS number and food facility registration well before your first shipment to the United States. 

If you filed a food facility registration with FDA and received an email with the subject line, “Pending Unique Facility Identifier” with a Reference Code, this means your DUNS number is under review and your registration is not yet active. If you received an email with subject line, “Unique Facility Identifier Verification,” FDA may have completed its review of the provided DUNS number and determined that it is not acceptable. 

Get assistance with FDA Food Facility Registration and DUNS number compliance. 

Food Facilities With Current FDA Registration 

If you have previously registered as a food facility with FDA, take note: FDA is actively reviewing all registrations in its database and contacting facilities whose DUNS numbers are not found “acceptable.” FDA is then advising that an acceptable DUNS number must be provided within 30 days of the notice, or face cancellation.  

As of September 15, 2023, in addition to this review, FDA’s database also performs an automated DUNS verification process on newly updated registrations. This means that if your facility  changes ownership resulting in a new name, or if your company relocates to a new facility, FDA will only accept your updated registration “conditionally,” pending a review of the corresponding DUNS number.  

FDA will cancel a facility’s registration 30 days after such an update if the facility fails to provide an updated DUNS number that corroborates the new name or address of the facility. FDA began this new verification prFocess in September and the agency’s email notifications cited 30 days for corrective action.  

FDA has already begun notifying facilities of cancellation due to unacceptable UFIs. FDA’s most recent email about UFI verification states that facilities will need to re-register and be assigned a new FDA food facility registration number after obtaining an acceptable DUNS number.  

Let us help you update your existing Food Facility Registration or DUNS record. If you have questions regarding FDA Food facility Registration or any other FDA regulatory matters, please contact Registrar Corp by phone: +1-757-224-0177 or email.  

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Registrar Corp

World's Leading FDA Compliance Experts

Registrar Corp thrives on the collective expertise of over 200 professionals, including former FDA officials and experienced industry specialists. Our team of regulatory specialists is our greatest asset, offering deep insights into the latest and longstanding FDA regulations. With our simple, straightforward, and actionable articles, you can navigate the complex regulatory landscape with ease.

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