Background
The U.S. Food and Drug Administration (FDA) has implemented preventive control standards to better protect public health by strengthening the food safety system. Domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. must register with FDA. 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 to quickly notify facilities that may be affected.
Registrations
There is no fee for registration or updates to a registration. A food facility is required to submit an initial registration to FDA only once and then renew its registrationevery other year during the period beginning on October 1 and ending on December 31 of each even-numbered year. Registrants must use Form 3537 to register, renew or update a registration. This form is available online and in paper form.
FDA requires you to provide the following information:
- Facility name, address, phone number and emergency contact phone number
- Parent company name, address and phone number (if applicable)
- Name, address and phone number of the owner, operator or agent in charge
- Email address for the contact person of the facility or, in case of a foreign facility, the U.S. agent for the facility
- All trade names the facility uses
- Applicable food product categories, as listed on the registration form
- Name, address, and phone number of a foreign facility’s U.S. agent and phone number of the facility’s emergency contact if it is someone other than the U.S. agent
- Assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the Federal Food Drug & Cosmetic Act
- Certification that the information submitted is true and accurate and that the person submitting it is authorized to do so