What is FDA Food Facility Registration?
Under Section 415 of the Federal Food, Drug, and Cosmetic Act (as amended by FSMA), domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States must register with FDA. Registration is a federal legal requirement — not a voluntary programme.
FDA food facility registration gives FDA visibility into where food in the US supply chain is produced and stored, enabling rapid traceability in the event of an outbreak, contamination event, or recall.
Registration vs Inspection: Registration is not an inspection or approval. FDA does not review or approve your facility when you register. Registration simply notifies FDA of your facility's existence and location.
Who Must Register?
The registration requirement applies to:
- Domestic US food facilities that manufacture, process, pack, or hold food
- Foreign food facilities whose food is exported to the US or offered for import into the US
- Facilities that produce food for human consumption and animal food
Who is exempt from registration?
- Farms (primary production activities)
- Restaurants and retail food establishments
- Fishing vessels that do not process fish
- Facilities regulated exclusively by USDA (meat, poultry, certain egg products)
- Private residences where food is prepared for personal consumption
How to Register
Registration is completed online through the FDA Industry Systems (FIS) portal at access.fda.gov. Foreign facilities must designate a US Agent before or at the time of registration. The US Agent must be physically located in the United States and available during business hours to receive communications from FDA.
ClearPath assists with the registration process, US Agent designation, and biennial renewal for food facilities and importers entering the US market.
Biennial Renewal
FDA food facility registrations must be renewed every two years, during the October 1 to December 31 window of each even-numbered year. Failure to renew results in cancellation of the registration. Importing food from a facility with a cancelled registration can result in shipment refusal at the US border.
Need FDA registration assistance?
ClearPath handles FDA food facility registration and biennial renewal for domestic and foreign facilities. Fixed fee of $149.
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