Facility Registration

Owners, operators, or agents in charge may choose to authorize an individual or a customs broker to register on behalf of the facility.

The requirement applies to each covered facility, not to firms or companies as a whole (e.g., a company with 10 facilities must register each one separately).

Registration is one time, not annual. However, changes to facility registration data must be updated with the FDA within 60 days.

Foreign Food Facilities
Foreign food facilities that manufacture, process, pack or hold food are required to have a US agent to register with FDA. The agent can be any "person" that resides or maintains a place of business in the US and is physically present in the US. The designated US agent acts as a communications liaison between FDA and the facility for both routine and emergency communications.

If a foreign facility that manufactures, processes, packs or holds food sends it to another foreign food facility for further manufacturing, processing or packaging before the food is exported to the US, only the last foreign facility is required to register, except if the subsequent facility is conducting de minimis activities such as labeling. In such cases, both facilities must register.

Exemption
The following entities are exempted from the registration requirement:

• Private residences of individuals
• Non-bottled water and drinking water collection and distribution establishments
• Transport vehicles and transport facilities that hold food only in the usual course of their business as carriers
• Farms
• Restaurants
• Retail food establishments
• Non-profit food establishments
• Fishing vessels
• Facilities regulated exclusively by USDA

Registration Method
Electronic registration is encouraged and can be accomplished worldwide, 24 hours a day, 7 days a week. Online registration is available at http://fda.gov.

Paper registration is also accepted if Internet access is not readily available. Please note that it’s a much slower process, and you need to ensure that the form is complete and legible.

FedEx Trade Networks can help you register your domestic and/or foreign facilities for a fee. For more information on the service, please visit FedEx Trade Networks FDA site at http://fda.ftn.fedex.com or call 1.800.249.2953 for more information on the service.

The following instructions and forms are available for download from the FDA web site. The completed PDF form may be printed and mailed to the US Food and Drug Administration, HFS-681, 5600 Fishers Lane, Rockville, MD 20857, or faxed to 1.301.210.0247.

Download Forms and Instructions:

• Instructions for filling out paper Forms 3537 and 3537a (PDF)
• Food Facility Registration Form (DHHS/FDA Form No. 3537) (PDF)
• Cancellation of Food Facility Registration Form (DHHS/FDA Form No. 3537a) (PDF)

FedEx will continue to monitor the status of the new provisions and periodically update the site. We strongly encourage you to regularly visit this site to stay informed of future updates.