The U.S. Food & Drug Administration (FDA) facility registration period begins October 1, 2018 through to December 31st, 2018. 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. All applicable facilities involved in the production and/or import of applicable products should renew their facility registration during this time.
Failure to register a facility during this period may limit the ability of importers to enter food product(s) into the U.S.
Parties can either register on-line or use FDA Form 3537. The completed form can be faxed or mailed to:
U.S. Food and Drug Administration
Food Facility Registration (HFS-681)
5001 Campus Drive
College Park, MD 20740
Fax: 301-436-2804
For on-line system, access or registration issues, please contact the FDA Industry Systems Help Desk at furls@fda.gov, toll-free in the USA 1-800-216-7331, or 240-247-8804.
Also note:
- If you registered your food facility before October 1, 2018, you must renew your registration before December 31, 2018 and provide the FDA with any updated information, if applicable.
- If you updated your food facility registration before October 1, 2018, you must renew your registration before December 31, 2018 and provide the FDA with any updated information, if applicable.
- If you are the new owner of a registered food facility, the previous owner is required to cancel the food facility’s registration within 60 calendar days of the change of ownership and you must re-register the facility reflecting the new ownership.
Please contact your local Delmar International representative or our North American Customs Advisory Services Group at AdvisoryServices@delmarusa.com for additional information and assistance.
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