US Agent for FDA Food Facility Registration

Who Needs Food Facility Registration?

Food facility registration applies to domestic and foreign facilities that handle food for US consumers, including:

• Food and beverage manufacturers and processors
• Dietary supplement and nutraceutical manufacturers
• Ayurvedic and herbal product facilities whose products are sold as food or dietary supplements
• Packers, re-packers and warehouses that hold food before export
• Animal food and pet food facilities

Farms, restaurants and retail food establishments are generally exempt. Foreign facilities are exempt only if another foreign facility does further manufacturing or processing (beyond labeling or similar minor activity) before the food is exported to the US.

Information Required for Food Facility Registration

• Facility name, address and Unique Facility Identifier (UFI). FDA currently accepts a DUNS number as the UFI.
• Parent company and owner, operator or agent in charge details
• Emergency contact for the facility
• All trade names used by the facility
• Applicable food product categories and activity types (manufacturing, packing, holding, etc.)
• US Agent name and contact details (foreign facilities only)
• An assurance that FDA will be allowed to inspect the facility

FDA does not charge a fee for food facility registration.

Biennial Renewal of Food Facility Registration

Food facility registration must be renewed every even-numbered year between October 1 and December 31. A registration that is not renewed in time is considered expired, and FDA may cancel it. Shipments from a facility without a valid registration can be held at the US port of entry.

Changes such as a new owner, address or US Agent must be updated within 60 days. FDA biennial renewal requirements

Role of the US Agent in Food Facility Registration

Every foreign food facility must name a US Agent who lives in, or has a place of business in, the United States. FDA asks the US Agent to verify the appointment before the registration is accepted. The US Agent is FDA's contact for routine and emergency communication about your facility. MedDeviceCorp provides this US FDA Agent service together with registration, so you deal with one team.

Our Food Facility Registration Process

1. Review – we confirm your facility type, product categories and whether registration is required.
2. DUNS / UFI – we check your DUNS number or help you obtain one.
3. Registration – we submit your food facility registration in FDA's Food Facility Registration Module.
4. US Agent verification – we accept our appointment as your US Agent.
5. Registration number – you receive your FDA food facility registration number and PIN.
6. Renewal and updates – we remind you before every biennial renewal and update changes on time.

Food Product Categories and Activity Types

FDA asks every facility to choose the food product categories it handles and the activities it carries out for each category. Choosing them correctly matters, because FDA uses this information to plan inspections and to respond quickly in a food safety emergency. Common categories include bakery products, beverages, dietary supplements, spices and herbs, snack foods, fruit and vegetable products, and food packaging that contacts food.

Activity types include manufacturing or processing, packing, labeling and holding (warehousing). A facility that both manufactures and stores a product selects both activities. If your product range or activities change, the registration must be updated so that it matches what the facility actually does.

Common Reasons Food Facility Registrations Fail

• DUNS details do not match – the facility name and address on the DUNS record must match the registration exactly.
• US Agent does not verify – FDA asks the US Agent to confirm the appointment. If no one responds, the registration cannot be completed.
• Wrong address type – a head office or trading company address is used instead of the actual facility address.
• Missed biennial renewal – registrations not renewed between October 1 and December 31 of an even-numbered year are treated as expired.
• Outdated details – changes of owner, US Agent or emergency contact not updated within 60 days.

What Comes After Food Facility Registration?

Registration is the first step, not the last. Before food is shipped to the US, a Prior Notice must be submitted to FDA for each shipment. US importers must also meet the Foreign Supplier Verification Program (FSVP), which means they will ask you for evidence that your food is produced safely. Depending on your product, preventive controls, labeling and nutrition facts rules also apply. FDA – Food facility renewal requirements

Why Choose MedDeviceCorp for Food Facility Registration?

At MedDeviceCorp, one team of regulatory specialists prepares your food facility registration, acts as your US FDA Agent and tracks every renewal date, so you are not juggling separate providers.

• Registration prepared and checked by regulatory specialists, not a form-filling service
• US Agent confirmation handled promptly when FDA sends the request
• Renewal reminders well before each FDA window opens
• Support with related FDA, EU Representative and UK Responsible Person requirements

Food Facility Registration FAQs

Related services: FDA Registration · US FDA Agent · Drug Establishment Registration · Cosmetic Facility Registration · Medical Device Establishment Registration