Food Facility Biennial Registration Renewal Due by 12/31/14
September 29, 2014 - Kestrel Food Safety
Food facilities required to register with the FDA must complete the biennial renewal of their food facility registrations this year. Facilities have from October 1, 2014 until December 31, 2014 to complete this renewal. If a registration is not renewed by 11:59 p.m. on December 31, 2014, the registration is considered expired.
The FDA Food Safety Modernization Act (FSMA) amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in part, to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the U.S. submit additional registration information to FDA. Section 415 also requires these facilities to renew such registrations every even-numbered year.
Registrants must use Form 3537 to register and/or renew a registration. Facilities may register online at www.fda.gov/furls or by mail or fax. Note that updating your registration is a different function than renewing your registration.
The following information is required for domestic and foreign food facility registrations:
- 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
- Certification that the information submitted is true and accurate and that the person submitting the registration is authorized to do so
- Assurance that FDA will be permitted to inspect the facility at the times and in the manner permitted by the FD&C Act
Other Issues to Consider
When completing the biennial review, this can be a good time for facilities to also consider the following:
- Commissioning and re-commissioning of food plants and operations centers
- Implementing program updates
- Completing internal audits
- Closing Corrective and Preventive Actions (CAPAs)
Kestrel is qualified to provide assistance with the renewal process, as well as these activities, to help ensure the safety and quality food produced in the U.S.
Submitted by: Bill Bremer