Update 06/03/2022:
The next food facility registration renewal period begins October 1st and continues through December 31st. In preparation for this upcoming renewal season, FDA recently began validating the UFI status of existing registrations. The information listed on the facility registration must match exactly what is listed with Dun & Bradstreet. Any facility with a “PENDING” UFI or inconsistent company name or address information within the Dun & Bradstreet database risks cancellation of its facility registration if the information is not corrected by the end of the renewal season. FDA Issues Notices to Food Facilities with Inadequate UFI Status.
Original Post 04/26/2022:
The U.S. Food & Drug Administration (FDA) recently increased its focus on auditing and imposing penalties for food companies who registered with FDA using misleading and/or inaccurate information. Entities engaged in food manufacturing, processing, packing, and holding must register with the Agency through the FDA’s Unified Registration Listing Systems (FURLS) every even-numbered year; this biannual registration allows the FDA to monitor risks associated with food processing, reduce the possibility of food-borne diseases, and make sure the facilities remain compliant with current food safety standards.
Recently, it was discovered that certain foreign companies importing food into the U.S. may have intentionally misregistered their manufacturing facilities with FDA, labeling themselves (the food company) as the product manufacturer. Actions such as these essentially prevent the identification of this crucial point in the supply chain and create a shield – preventing the divulgence of the actual manufacturer. Apart from obviously being misleading, these actions can also be harmful to consumers should the true manufacturer be a negligent source or one that does not recognize the importance of compliance with relevant safety standards.
Failure to provide correct and accurate registration information prevents the Agency from performing its duty in safeguarding consumers from dangerous products. If the FDA attempts to schedule an inspection with a false facility, the company would have no facility to inspect, essentially defaulting to a “failure to comply with inspection requests.” FDA may then take action and place the miscategorized company on the Red List, citing Import alert 99-32; “Detention without Physical Examination of Products from Foreign Establishments Refusing FDA Inspection.” Import Alerts like this will make it difficult for a product to be sold in the U.S. because shipments from the miscategorized company will be subject to FDA automatic detention.
Using misleading information during registration might initially seem beneficial for those who wish to keep their supply chain ambiguous, but doing so will likely invite enforcement and, eventually, severe civil monetary penalties. Food companies should endeavor to register each segment of their supply chain wholly and correctly to avoid being placed on Import Alert.
It’s important to note that Import Alerts do not have to be permanent; however, if you choose to do nothing when faced with the issuance of an Import Alert, they certainly will be. If you or your company find yourself in this situation, you can do something to move your company onto the Green List or off of Red List status. If your company is on Import Alert, we can guide your investigations and corrective actions to align with the FDA’s expectations. If you are a food facility seeking preemptive registration services or a distributor seeking to minimize compliance risk, please call us at 410-220-2800 or contact us today.
