FDA Biennial Registration Renewal
We do apologize for the late notice. If you have not already done so, please remember to complete your Biennial FDA Registration Renewal before 12/31/24. If you do not complete the renewal, then your registration will be cancelled and you will need to reapply. That means you will not be able to ship your product to the US until you obtain a new registration number. If you are not a manufacturer of an item subject to FDA, then you may want to forward this reminder to your suppliers who are a manufacturer. If... Read More
Blaine FDA to Restrict Hours of Operation
The Blaine, WA station of the FDA will restrict its hours of operation from 8:00 a.m. to 4:00 p.m. Monday through Friday excluding holidays. Merchandise to be examined must arrive by 3:00 p.m. The adjustment of operating hours is temporary, though no date has been provided for resumption of the regular hours. We will update this information as it becomes available from the FDA. Read More
Change in Blaine FDA hours
The Blaine station of the FDA announced a change in their operating hours beginning September 7, 2022. The new hours are from 7:00 a.m. to 8:00 p.m. Monday through Friday excluding Holidays. The changes will remain in effect until we are notified otherwise. Read More
FSVP – DUNS NUMBER (“UNK” TO TERMINATE JULY 2022)
UPDATE (JUNE 14TH, 2021) No More ‘UNK’ for FDA Entries in July 2022 The Food and Drug Administration (FDA) told NCBFAA Regulatory Affairs Committee (RAC) members that use of the term “UNK” (representing “unknown”) will not be allowed for food imports in place of a valid DUNS number for in the Unique Facility Identifier field for the FSVP importer, starting July 2022. The agency has already started targeted outreach by sending emails to customs brokers and importers... Read More
PREPARING FOR THE 2020 BIENNIAL REGISTRATION RENEWAL
The announcement below is for our FDA clients who have an FDA Registration Number. Preparing for the 2020 Biennial Registration Renewal In preparation for the 2020 Biennial Registration Renewal period, we have a few tips: Ensure that your FURLS account is up to date with a valid password Please visit https://www.access.fda.gov/ to access your account. If you have forgotten your Account ID and/or password, please select ‘Forgot Account ID’ and/or ‘Forgot Password’ to obtain your... Read More
Final Notice – FDA BIENNIAL REGISTRATION! ENDS DEC 31, 2018
If you are a Food Producer and have an FDA Registration – this will be your final notice to complete your Biennial FDA Registration. The clock is ticking and your time runs out at 9:00 p.m. PST on December 31, 2018. Don’t forget! Read More
FDA BIENNIAL RE-REGISTRATION OCT 1ST THROUGH DEC 31, 2018
The 2016 Biennial Registration Renewal Period begins Saturday, October 1, 2018 and ends on Saturday, December 31, 2018 at 11:59 PM. Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d] requires food facilities required to register with FDA to renew such registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year. If you register your food facility before October 1, 2018, you must renew your registration before... Read More
FDA – FSVC Food Safety Verification Program
Starting May 27 2017 the FDA Will being implementing the FDA’s Food Supplier Verification Program (FSVP). The central point in this risk based program requires that the ultimate purchaser in the USA to whom the FDA have identified as the importer or the person in the USA purchasing or buying the goods supply to the broker, 1) The DUNS# and 2) The FDA Registration Number. To repeat the these numbers must be from the U.S. buyer / importer of the goods. A Canadian foreign Importer of Record... Read More
FDA Biennial Registration Notice
The 2016 Biennial Registration Renewal Period begins Saturday, October 1, 2016 and ends on Saturday, December 31, 2016 at 11:59 PM. Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d] requires food facilities required to register with FDA to renew such registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year. If you register your food facility before October 1, 2016, you must renew your registration before... Read More
DIETARY SUPPLEMENTS – Revised Draft Premarket Guidance
Release: The U.S. Food and Drug Administration today issued a revised draft guidance to improve dietary supplement companies’ new dietary ingredient (NDI) premarket safety notifications to the agency. These notifications help the agency identify safety concerns before products reach consumers. Under the Dietary Supplement Health and Education Act (DSHEA), the manufacturer or distributor must notify the FDA at least 75 days before beginning to market a dietary supplement that contains a new... Read More
