FDA Registration & US Agent Service

The Bioterrorism Act of 2002 and the Food Safety Modernization Act (FSMA) of 2011 require domestic and foreign food facilities that manufacture, process, pack or hold food for human or animal consumption in the United States to register with the FDA. As part of this requirement, foreign food facilities must designate a US Agent to complete their registration and act as a communication link between each food facility and the US FDA. During the registration process, food facilities are required to include a unique facility identifier (UFI) as part of their registration information. The FSMA also permits the FDA to inspect registered facilities at any time  and in manner as outlined in the FD & C Act. All FDA food facility registrations are required to be renewed biennially. A food facility registration may be suspended by the US FDA under certain circumstances. Failure to adequately register a foreign food facility with the FDA may result in the detention of food products at the  US port of entry  during export.

US Agent Appointment

Before a foreign food facility can register with the US FDA, the owner, operator or agent in charge must appoint US Agent. A US Agent is an individual, partnership, corporation or association and must have a place of  business or residence in the United States. The US Agent must be physically present in the United States. As your US Agent, Professional Food Consultation Services will take care of your FDA registration and renewal, and handle any communications between the US FDA and your facility.

Unique Facility Identifier (UFI)

All food facilities registering with the US FDA are required to have a unique facility identifier that is recognizable.  The unique facility identifier is used by the FDA to verify that the registration information submitted by a food facility, such as it's address, is accurate. The US FDA currently recognizes the Data Universal Numbering System (DUNS) number as an acceptable UFI. If you do not have a DUNS number for your food facility, Professional Food Consultation Services will help you to obtain one.

Update to Food Facility Registration

Food facilities registered with  US FDA are required to submit an update to their facility's registration within 60 days if there is a change to any of their required registration information. The  update can be submitted by the owner, operator, agent in charge or an authorized third party.

Biennial Registration Renewal

The FSMA Act requires food facilities already registered with the US FDA to renew their registration biennially. FDA registration renewal must be submitted every even number year between October 1 and December 31. Failure to renew a registration within the designated time frame will result in the expiration of the registration and would require the food facility to be reregistered before any of its foods can enter the US.

Registration Certificate

Once your food facility registration is confirmed by the US FDA, Professional Food Consultation Services will issue a registration certificate with your assigned registration number. The registration certificate is a record of service between your food facility and your US agent. The US FDA does not issue, nor do they recognize a registration certificate. Food facilities will also be able to access and confirm their registration via FDA Industry System.

US FDA Affiliation

Professional Food Consultation Services is a private entity and is not affiliated or a part of the US FDA.