For Foreign Food Facilities
U.S. Agent Services
Foreign food facilities that export food to the United States are required by FDA regulations to designate a U.S. Agent. We provide reliable, responsive U.S. Agent services — and include this designation in our foreign registration and renewal packages.
The FDA U.S. Agent Requirement
Under 21 CFR Part 1, Subpart H, every foreign food facility registered with the FDA must designate a U.S. Agent.
The FDA Food Safety Modernization Act (FSMA) and the Bioterrorism Act require all foreign food facilities that manufacture, process, pack, or hold food for consumption in the United States to register with the FDA and to designate a U.S. Agent.
The U.S. Agent must be a person or entity physically located in the United States and available during normal business hours. The U.S. Agent serves as the FDA's primary point of contact for the foreign facility for all regulatory communications, inspection notifications, and compliance matters.
Failure to designate a valid U.S. Agent — or designating an agent who is unavailable or unresponsive — can result in suspension of the facility's FDA registration and prohibition from importing food into the United States.
Key Requirement Summary
- Must be physically located in the United States
- Must be available during normal U.S. business hours
- Listed on the FDA food facility registration
- Receives all FDA regulatory communications
- Required for all foreign registered facilities
Our U.S. Agent Responsibilities
FDA Point of Contact
We serve as the official U.S. Agent listed on your FDA registration, acting as the FDA's primary contact for all regulatory communications regarding your facility.
Inspection Notification
We promptly notify your facility of any FDA inspection notices, requests for information, or regulatory correspondence received on your behalf.
Regulatory Correspondence Management
We receive, review, and forward all FDA communications to your facility, ensuring nothing is missed and responses are handled in a timely manner.
Emergency Contact Availability
We maintain availability during U.S. business hours to respond to urgent FDA inquiries, import alerts, or detention notices affecting your shipments.
Registration Maintenance Support
We assist with keeping your FDA registration current, including biennial renewal and any required amendments to your registration information.
Import Issue Coordination
In the event of an FDA import hold, refusal, or detention, we coordinate communications between your facility and the FDA to help resolve the issue efficiently.
U.S. Agent Service Pricing
Included in Foreign Registration & Renewal Packages
U.S. Agent designation is included at no additional charge in our Foreign FDA Food Facility Registration ($910.00) and Foreign FDA Registration Renewal ($910.00) packages. If you are registering or renewing with us, you do not need to purchase standalone U.S. Agent services.
View Registration PackagesStandalone U.S. Agent Service
Contact for Pricing
If you already have an active FDA registration and need to update or replace your U.S. Agent, or if you require standalone U.S. Agent services, please contact us for a customized quote.
Contact UsFrequently Asked Questions
Common questions about FDA U.S. Agent requirements for foreign food facilities.
Need a U.S. Agent for Your Foreign Facility?
Whether you're registering for the first time or need to update your existing U.S. Agent designation, we're here to help.