All About FDA Facility Registration for Food Products
All U.S. and foreign facilities that manufacture, process, pack or store food and/or beverages to be consumed in the United States must register with the Food and Drug Administration (FDA). Before importing food or beverages for sale in the U.S., familiarize yourself with these guidelines on registering your food facility with the FDA.
When to Register a Food Facility
The FDA requires food facilities to register before importing food into the U.S. in order to avoid regulatory enforcement action. After registering, you will receive a food facility number confirming your FDA registration. Most customers and suppliers, as well as customs officials, will require proof of U.S. FDA registration.
Renewing a Food Facility Registration
The Food Safety Modernization Act initiated the requirement of renewing food facility registrations every other year. Failure to renew a registration results in an expired registration. Food products offered for import with an expired registration will be refused entry into the United States. Renewals must be filed between October 1 and December 31 of every even-numbered year.
Food Facility Suspension
If the FDA determines that food manufactured, processed, packed, received, or held by a registered food facility has a reasonable probability of causing serious adverse health consequences or death, the FDA may by order suspend the registration of a facility that:
- Created, caused, or was otherwise responsible for such reasonable probability; or
- Knew of, or had reason to know of, such reasonable probability; and packed, received, or held such food.
Foreign Facilities
For facilities not located in the United States, when completing your registration you must appoint a U.S. Agent physically located in the U.S. to communicate with FDA. A U.S. Agent must be available to assist the FDA in communications with the facility, respond to questions concerning the facility's products offered for import and assist the FDA in scheduling facility inspections.
How US Imports Can Help
US Imports can register your domestic or foreign food facility with the FDA and if your facility is located outside of the United States, we can also serve as the U.S. Agent. US Imports can provide you with a certificate confirming your registration with the FDA. US Imports makes FDA compliance easy. Let us register your food facility today and keep your food business on track for FDA compliance.
