Domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the United States must register with the Food and Drug Administration (FDA). Under the Food Safety Modernization Act (FSMA), all facility registrations should be renewed between October and December every even-numbered year.
Since the beginning of this year, thousands of foreign food facilities have learned their facility registration was cancelled.  The majority of registration cancellations could be attributed to a failure by companies to renew their registration or a failure by US agents to confirm the registration.

Foreign companies should verify their food facility registration is valid before attempting to ship product to the United States.  Companies can resolve FDA registration problems by re-registering their facility through the online registration system. A successful registration requires email confirmation by the US agent identified in the registration form.   
For the 2016 registration process, FDA imposed a new requirement for U.S. agents to confirm each registration. Also, the FDA facility registration process requires that companies identify the ‘activity type’ for each facility by selecting from a list of 39 activity types for human food or 28 activity types for animal food. Moreover, the latest facility registration process required companies to agree to an FDA inspection.  
Since July 2016, the FDA has issued new guidance documents and related materials to support compliance with the facility registration process.

An estimated 114,000 foreign food facilities from more than 200 countries export food to the United States, according to recent government data. In fact, recent government estimates suggest 20% of the food consumed by Americans is imported food.  

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Source:  U.S. Food and Drug Administration