FDA Facility Registration

The FDA Bioterrorism Act requires all domestic and foreign food facilities to register with the U.S. Food and Drug Administration (FDA). Food facilities include all facilities that manufacture, process, pack, or hold food or beverages, for importation or distribution in the United States.

About the Registration Requirement

The U.S. FDA Food Safety Modernization Act (FSMA) requires all domestic and foreign food facilities to renew their FDA Food Facility Registrations between October 1, and December 31, and biennially (every two years on even years) thereafter. Food facilities that did not renew their registration by January 1 must re-register and obtain a new registration number.

Who Must Register?

Food facility registration is required by the U.S. FDA for all domestic and foreign companies that manufacture, process, pack, or store food, beverages (including alcoholic beverages), or dietary supplements that may be consumed in the United States. Companies located outside the United States must designate a U.S. Agent to communicate with the U.S. FDA.

Do I Need a DUNS Number?

All domestic and foreign food facilities are now required to provide a Unique Facility Identifier (UFI) when registering with FDA or renewing food facility registration with FDA. A DUNS number is the only acceptable UFI recognized by FDA for now. If you need assistance in obtaining a DUNS number, contact us at info@diaztradeconsulting.com.

U.S. Agent Responsibilities

The U.S. Agent is responsible for being readily available to respond to FDA communications. FDA will communicate with the designated U.S. Agent, to schedule inspections and require an immediate response. The U.S. Agent is a person or entity located within, or that maintains an office, in the United States.

Register Online In English

If your company desires to hire Diaz Trade Consulting for its FDA registration and you are having difficulty completing the form or otherwise with the website, please contact jen@diaztradeconsulting.com.
Diaz Trade Consulting provides both FDA registration and renewal services. Certificates of Registration issued by Diaz Trade Consulting provide confirmation to industry that you are fulfilling U.S. FDA registration requirements which may help avoid costly delays.

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