Quality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and Drug FDA domestic and foreign facilities!
The process of food facility registration can be complex, but knowing what is required and following the instructions carefully helps ensure a successful registration. In this guide, you will find the answers to your questions about the steps you need to take for proper food facility registration with the US Food and Drug Administration (FDA).
Why is Food Facility Registration & Renewal Important?
Individuals such as owners, operators, or agents that oversee domestic or foreign facilities that manufacture, process, or package food for consumption in the United States are required to register their food facility with the FDA. This requirement along with the FDA being given advance notice on shipments of imported food (Prior Notice of Imported Foods) became effective by the Bioterrorism Act on December 12th, 2003, as a protective to protect the U.S. food supply.
What is FDA food facility registration?
A food facility registration is the process of registering a business to legally operate as a provider of food products in the United States. Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA), requires food facilities to register with the FDA and to renew such registrations every other year.
Who needs to register their FDA facility?
Any facility, business, or organization that is engaged in manufacturing, processing, packing, or holding food for consumption in the United States is required to register its facility with the FDA. Food facility registrations must also be renewed on a biennial basis.
What information needs to be submitted for FDA facility registration?
For a successful food facility registration, several pieces of information are typically required including the facility location, the contact person for the facility, and US agent information (if the facility is located outside of the United States). It is also a requirement to submit information on the activities and types of food products that will be handled at the facility location.
What other requirements should I consider before registering my FDA facility?
When registering your food facility, other considerations should include the type of business, the type and quantity of products you will be producing, and any health department regulations relating to your food items or manufacturing processes. Additionally, when handling food products that are susceptible to contamination or spoilage, it’s essential to identify potential risks and design a Food Safety Plan to meet safety standards set by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the Department of Agriculture (USDA).
How will I know when my FDA facility registration is approved?
Once the registration has been drafted and submitted to the FDA, a confirmation email will be sent to the contact person for the facility. Furthermore, a food facility registration number will be issued to the facility. This number is important to keep on file, as it confirms that the facility is successfully registered with the FDA.
How Quality Smart Solutions can help
We can guide you through the entire FDA Facility Registration or FDA Facility Renewal process for domestic and foreign Food facilities.
We’re here to serve your regulatory needs, so please reach out to us at firstname.lastname@example.org with any regulatory questions.