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FDA Tweaks Acceptable Facility Registration UFI Guidelines

I visited the THAT Brewery Production Facility in Cottonwood (http://thatbrewery.com/) to take some photos for the owners. It was exciting to see the new canning line in operation, assembling this stack of Arizona Trail Ale. It’s available in Whole Foods in Arizona and many other local stores (including mine, the Ponderosa Market in Pine)

The FDA released a revised manual earlier this month outlining how to abide by the obligation of the FDA to have a Unique Facility Identifier (UFI) accepted as appropriate by the FDA when requesting registration or renewal of a food facility. The guideline also offers information about what to do should a facility be unable to receive a Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) number promptly before the end of the biennial renewal period, which is the end of the month.

As a note, the UFI of a facility must be sent with the registration details starting October 1, 2020. To ensure that the facility-specific address associated with the UFI is the same as that of the one associated with the registration of the facility, the UFI will be used. The FDA continues to accept the DUNS number as an appropriate UFI.

The FDA proposes to let registrants who expect to be momentarily unable to supply their registration or renewal with a DUNS number to put “PENDING” in the UFI registration area. This provisional entry would allow registrations and renewals submission to continue even though a DUNS number has yet to be issued by the registrant. Upon application, the registrant has 90 calendar days to change its DUNS number for registration. If a register with a current DUNS number is not changed within that period, the registration will be canceled.

To view the updated guidance, please visit https://www.fda.gov/media/143997/download.

A&L Registration is committed to assisting domestic and foreign clients in navigating and simplifying the often convoluted process of registering with the FDA. We have worked with an extensive array of clients across a broad spectrum of industries such as cosmetics, food and beverage, medical devices, and more through providing experienced, researched, and professional advice on FDA compliance and its multitude of legal regulations. For more information on FDA registration, please visit our website or call 786-504-6363.

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