Sanders Brokerage » FDA

FDA Biennial Registration Renewal

Brion Cortez — Thu, 19 Dec 2024 00:18:00 +0000

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 you need it, the website is https://www.fda.gov/food/online-registration-food-facilities/food-facility-registration-user-guide-biennial-registration-renewal.

Please contact us if you have any questions.

Thank you.

Blaine FDA to Restrict Hours of Operation

Brion Cortez — Fri, 01 Dec 2023 20:43:10 +0000

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.

Change in Blaine FDA hours

Brion Cortez — Tue, 06 Sep 2022 22:29:35 +0000

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.

PREPARING FOR THE 2020 BIENNIAL REGISTRATION RENEWAL

Brion Cortez — Fri, 21 Aug 2020 20:01:21 +0000

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 login information. If you have not accessed your account in over 90 days, you will be required to create a new password. Please visit https://www.fda.gov/food/online-registration-food-facilities/fda-industry-systems-account-management-guide for more information on managing your account or resetting your password. If you require further assistance, please call our FURLS Helpdesk at 1-800-216-7331 or 240-247-8804 or email FURLS@fda.gov. Due to the high call and email volume received during the renewal period, we encourage you to contact us in advance of the renewal period for account management assistance.

Obtain or verify your facility unique facility identifier (UFI)

In accordance with 21 CFR 1.232(a)(2), beginning October 1, 2020, the facility’s UFI recognized as acceptable by FDA will be required to be submitted with the registration information. At this time, FDA recognizes the Data Universal Numbering System D-U-N-S (DUNS) number as an acceptable UFI. DUNS numbers are assigned and managed by Dun & Bradstreet. Please visit the FDA DUNS Portal at https://fdadunslookup.com/ in order to obtain or verify your DUNS number. As a new user of the portal, you will need to create an account in order to access the portal. User guides and instructions can be found at https://fdadunslookup.com/FDA%20DUNS%20Portal%20User%20Guide.pdf. For assistance, we encourage users to create and log in to their account and initiate an inquiry from the portal. For general DUNS inquiries, please email DUNSLookupSupport@dnb.com.

The 2020 Biennial Registration Renewal period begins October 1, 2020 and concludes on December 31, 2020. Please look for more information in the coming weeks.

FDA Import Complaince

stevelsanders98230 — Wed, 25 Jul 2012 08:19:15 +0000

FDA Regulatory Compliance: If you haven’t noticed we would have to say that the United States Food & Drug Administration (FDA) has been advised to turn up the heat on import compliance. This is strictly our opinion but locally we have seen FDA exam and sample more importations with the apparent end result being compliance to all FDA import regulations such as: the cosmetic labeling act; food labeling act; and other import regulations. Importers are advised to ensure their their labels, websites and published brochures do not reference unsupported medical claims. Making medical claims could infer to FDA that your product might be a drug, and as you may know the importation into the USA of unapproved drugs is restricted (drugs must be registered and listed with the FDA). Please check out our links for further helpful FDA information:

http://www.sandersbrokerage.com/dev/resources/tools/links/f-d-a-links/