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FDA Issues Guidance on Food Facility Registrations and Renewals

Dec 19, 2012

The Food and Drug Administration's Food Safety Modernization Act (FSMA) amended registration requirements for domestic and foreign food facilities that manufacture, process, pack or hold food for human or animal consumption in the United States. Food facilities that are required to register with FDA must renew their registrations with the agency between October 1 and December 31 of each even-numbered year.

Noting the delay in the implementation of registration for the 2012 cycle, FDA issued last week a guidance document stating the agency intends to exercise enforcement discretion for registration renewals submitted through January 31, 2013. FDA still encourages facilities to renew early, if possible. See Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Fifth Edition) for questions and answers regarding food facility registration. 

FDA also issued Guidance for Industry: What You Need to Know About the Registration of Food Facilities – Small Entity Compliance Guide. This document details:

  • who is required to register and who may be exempt;
  • how often facilities must register and renew registrations;
  • when FDA may suspend a registration, and
  • how facilities may submit their registrations and registration renewals to FDA. 

Additional information that must be provided for each facility registration includes the email address of the U.S. agent for the foreign facility and an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by FSMA.

For more information, members may contact Clay Detlefsen, IDFA vice president of regulatory affairs, at

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