mdi ConsultantsAs a part of The Public Health Security and Bio-terrorism Preparedness and Response Act of 2002 (the Bio-terrorism Act) FDA established regulation that require Food facility to be registered with FDA and give advance notice to FDA on shipments of imported food.
The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States submit additional registration information to FDA, including an assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act. Section 415 of the FD&C Act, as amended by FSMA, also requires food facilities required to register with FDA to renew such registrations every other year, and provides FDA with authority to suspend the registration of a food facility in certain circumstances.
The 2016 Biennial Registration Renewal Period begins Saturday, October 1, 2016 and ends on Saturday, December 31, 2016 at 11:59 PM.
The owner, operator, or agent in charge of the facility, or a person authorized by one of them, can submit registration renewal electronically.
Alternatively, you may submit your registration renewal via mail or fax using FDA Form 3537.
Form FDA 3537 is available for download.
You can request the paper forms and submit completed forms by fax to 301-436-2804 or by mail to:
U.S. Food and Drug Administration
Food Facility Registration (HFS-681)
5001 Campus Drive
College Park, MD 20740.
You also may request the paper forms by phone at 1-800-216-7331 or 301-575-0156.
mdi Consultants Inc., can assist you with your food facility registration, renewal of your biennial food registration and updating your registration details with FDA. Please contact us at [email protected] or use our contact form.