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INSIGHTS

Three Cheers for FDA Food Facility Registration Renewal

It’s that time of year again

Every even-numbered year, food facilities that are required to register with the FDA, must renew their registrations during the period beginning October 1 and ending December 31. Failure to renew a registration by 11:59PM on December 31, 2022 will result in a different kind of excitement New Year’s Eve – your registration will be considered expired and removed from your account!

Additionally, all facilities are required to include a unique facility identifier (UFI) recognized as acceptable to the FDA. FDA recognizes the Data Universal Numbering System (DUNS) as an acceptable UFI. DUNS numbers can be obtained or verified visiting D&B’s website.

To address stakeholder concerns with obtaining a DUNS number in a timely manner, FDA has released guidance, Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) for the 2020 Food Facility Registration Biennial Renewal Period, if a Company is not able to obtain a DUNS prior to the end of the renewal period. The guidance advises that FDA allows registrants to enter “Pending” in the UFI field of their registration if they do not anticipate their UFI in time. Users will then have 90 days to obtain and submit a DUNS number and will receive reminders via email.

So as adrenaline-rushing as it is to wait until the eleventh hour to renew your food facility registration, register on time and early so you can focus on ringing in the New Year!

★★★★★

Working with Shelly on various new product launches over the last couple of years has been seamless. Quick and clear guidance is always what we get.
R.G. Client
I've been working with Shelly and her team at Garg law for a little while now and they are fantastic! Very responsive, professional and they certainly get things done. Extremely satisfied with their service and highly recommend.
Mike H. Client
Ms Garg helped my company navigate an FDA import issue. She achieved an excellent result, was very responsive and professional, and managed to keep the project within budget. She is a stellar attorney.
Dr. Sastry Client
I have been using Shelly Garg as FDA Counsel for 10+ years, since she was at another international law firm. While we continued to use the previous firm she was at (mainly due to the process required to change firms), we realized the quality of counsel was not the same. We have since been using Garg Law and the ease of use and trust in the knowledge was back instantly. Shelly has the skills to help me understand the regulations (by translating into layman's terms) and risks in a manner that is specific to my business. She is also extremely timely in her responses which is critical when we have a deadline mandated by the FDA. Many other attorneys cite the regulations which l've already read, but need further counsel. In my opinion, this demonstrates Shelly's in-depth knowledge of the regulations, how they pertain to the law, and how they are applicable IRL. Shelly's personable approach and pleasant manner in communication makes it very easy to have been work with her and have productive discussions on the best next steps. She truly has a passion iternational for all things FDA and I've learned so much from her.
Claire P. Client

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