Import

FDA Food Facility Re-registration

Food facilities required to register with the Food and Drug Administration must renew their registrations between Oct. 1 and Dec. 31.

If you are an importer of food, check with your foreign suppliers or manufacturers to confirm they have re-registered with FDA.  If suppliers and manufactures have not, import shipments will be held at port of entry and delayed until re-registration has been completed.  Failure to register or renew a registration can also expose facilities to civil or criminal action.

If a food facility has previously registered with the FDA, it must re-register and that can only be done between October 1 and December 31. If you haven’t done this yet, you have 2 weeks!

FDA Registration Renewal

What happens if we don’t register between this time?

If a food facility does not register between this period, its prior registration will be invalidated by the FDA.  Thus, a US Customs clearance rejection may occur when importing from an invalidated foreign facility. In addition, food facility registrations will also be  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).

What does this mean?

If the time lapses, and if you are an importer experiencing a rejection or problems importing that you did not experience before, please ensure your foreign supplier has followed the steps to register their facility.  If they have already started the process, 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.  FURL information listed below.

Please note, registrations that have been invalidated cannot be renewed.   However, a new registration can be created.

It’s a simple fix. It just needs to get done.

Registrations can be done online, via mail or fax, although FDA encourages online registration.  The FDA even allows authorized third parties to register for the foreign facilities.

Note, regardless of how the facility is registered, 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.

FDA Registration Website

Download Common Q&A

Support Contact information

Manufacturers should contact the FURLS Help Desk at FURLS@fda.gov or call 1-800-216-7331 to verify the current status of your food facility registration. Due to the high call volume, please expect long wait times for phone calls. You may also access the Food Facility Registration Module (FFRM) to verify the status of your registration.

Trade may contact FDA ACE Support 24/7 at ACE_Support@fda.hhs.gov or 877-345-1101 for ACE inquiries to verify the rejection reason.

Trade may also contact the Division of Food Defense Targeting at prior.notice@fda.hhs.gov or 866-521-2297 for assistance with valid food registrations verified by the FURLS Help Desk that may be rejecting improperly.

FDA Resources:

Guidance Document Search
Establishment Registration & Device Listing
FDA ACE/ITDS DUNS Portal
US Customs and Border Protection

 

Questions? Email an FDA Expert Now.

 

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