Food Facility Registration

Facilities that are situated outside the United States that manufacture, process, pack, or store food, beverages, or dietary supplements that are to be consumed in the United States are required to be registered with the U.S. Food and Drug Administration (FDA). Such facilities require the appointment of a US Agent for communication with the FDA.

Facility handling any of the food products mentioned below shall be registered:

• Dietary supplements and dietary ingredients
• Infant formula 
• Beverages (including alcoholic beverages and bottled water)
• Fruits and vegetables
• Fish and seafood
• Dairy products and shell eggs 
• Raw agricultural commodities for use as food or components of food 
• Canned and frozen foods 
• Bakery goods, snack food, and candy (including chewing gum) 
• Live food animals, Food for animals (e.g., pet food, pet treats, and chews, animal feed)

Steps for FDA Food Facility Registration:

• Appoint a US Agent
• Create an Account on the FDA website and choose “Food facility Registrations”.
• Select “Register a food facility”.
• Fill in the required details in the 12 sections of the registration form.
• Review and submit the form.
• Generation of registration Number & PIN
• In the case of a foreign manufacturer, the FDA contacts the US agent of the organization and confirms that he has agreed to serve as US Agent.

Details of the Sections of the Registration Form:

• Section 1 – Type of Registration
• Section 2 – Facility Name / Address Information
• Section 3 – Optional: Preferred Mailing Address Information
• Section 4 – Parent Company Name / Address Information
• Section 5 – Facility Emergency Contact Information
• Section 6 – Trade Names
• Section 7 – United States Agent
• Section 8 – Seasonal Facility Dates of Operation
• Section 9 – General Product Categories – Human/Animal/Both
• Section 9a – General Product Categories – Food for Human Consumption; and Type of Activity Conducted at the Facility
• Section 9b – General Product Categories – Food for Animal Consumption; and Type of Activity Conducted at the Facility
• Section 10 – Owner, Operator, or Agent in Charge Information 
• Section 11 – Inspection Statement
• Section 12 – Certification Statement

FDA Food Facility Registration Renewal:

It is required for the facilities to renew their registrations every other year during the period from 1st October to December 31st of each even-numbered year.

This is mandatory as per Section 415 (a) (3).

Authorized food facilities can renew their FDA Food Facility Registration electronically through FURLS Food Facility Registration Module (FFRM).

In case the facility fails to renew the registration, the registration is considered to be expired. The FDA cancels the facility registrations.

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