Step 1: Appoint a USFDA agent

You must appoint an authorised USFDA agent before starting the food facility registration for your business. Such agent’s help the FDA in communicating with foreign establishments like yours. The agent will also assist the FDA in scheduling inspections and will respond on your behalf to all questions/communications from the FDA. To this end, you need to notify all information regarding your agent electronically via FURLS (FDA Unified Registration & Listing System).

Step 2:  Submit the USFDA registration application form

All foreign and domestic food businesses must submit a registration application on the online portal of the FDA unified registration and listing system.

Step 3: Issue of a registration number by the FDA

After successful completion of the registration process, the FDA will issue an 11-digit registration number.

Step 4: Issue of USFDA registration certificate

You will receive the registration certificate through your agent. 

Does a USFDA Registration Need to Be Renewed?

With effect from 2011, the FSMA made the renewal of the FDA certificate mandatory to ensure compliance with the USFDA guidelines. All facilities engaged in the packing, processing, manufacturing, or storing of foods, beverages, and nutraceuticals consumed in the United States have to renew their FDA registration. renewal can be done through authorised FDA agents.

Please note that the USFDA will cancel your registration if it is not renewed before the 31st of December every two years. All the food products exported after the expiry of the renewal deadline will be stopped at US ports. Such products will not be released to the owner, consignee, or the importer until the food facility registration is renewed or a new 11-digit USFDA registration number is obtained.

The Takeaway

As you can see, exporting food products to the US requires several different levels of licencing and registration. Disciplined adherence to stringent compliance guidelines is also demanded from those who wish to import food into America. PKMPL can help you with FDA registration as well as IEC registration. Moreover, we can also ensure compliance with USFDA guidelines at all times.