Guidance for Industry: What You Need To Know About Registration of Food Facilities; Small Entity Compliance Guide

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This guidance document is a restatement of the Food and Drug Administration’s (FDA’s) current requirements for registration of food facilities presented in simplified format and language. As guidance, it is not binding on either FDA or the public.

Purpose of this Guidance

This guidance was created to inform domestic and foreign food facilities about the food facility registration requirements. It contains important information that may affect your firm.

Food Facility Registration Requirement

Domestic and foreign facilities that manufacture, process, pack, or hold food, as defined 21 CFR 1.227, for human or animal consumption in the U.S. must register with FDA effective December 12, 2003.

Why Facility Registration Is Required

Food facility registration will help FDA to:

  • Determine the location and source of a potential bioterrorism incident or an outbreak of food-borne illness; and
  • Quickly notify facilities that may be affected.

What It Costs

There is no fee for registration or updates to a registration.