Blog

FDA Invalidation of registrations for failure to renew or complete the renewal process

FDA invalidated food facility registrations that failed to renew during the 2016 biennial registration period. In addition, food facility registration were invalidated for failure of confirmation by a US Agent and/or foreign manufacturer (registered by a third party) as required under the FDA Food Safety Modernization Act (FSMA), Section 415 of the Federal Food, Drug, and Cosmetics Act (FD&C Act) [21 U.S.C. § 350D] and in accordance with 21 CFR 1.231(a)(5) and (b)(7). (Please see related CSMS message 16-001052).

If you are receiving an entry rejection for an invalid registration, you will need to confirm the status of the registration with the manufacturer. The manufacturer may check the status of their registration by logging into their FURLS Food Facility Registration Module account to verify the status of the individual registration. Registrations that have been invalidated cannot be renewed and a new registration will have to be created. The US Agent or the owner must confirm the receipt of the registration within 30 days for it to be valid in the FDA reference database. Failure to have a valid registered manufacturer can cause a shipment delay greater than 24 hours, therefore it is not recommended to file a prior notice if the registration is pending or use a facility registration that was invalidated due to failure to renew or confirmed by the US Agent/Owner.

ACE information: For this reject the sub-reason code 112 is sent back in the SO transaction for entries, SO71 record. For Stand-Alone prior notice filings, in the PO transaction the code 112 is in the PO71 record.

Please contact OCEANAIR Compliance for more information at (781) 286-2700.