U.S. Agent Representation for Foreign Facilities

FDA Food Facility Registration Contact Requirement — Section 415 FD&C Act & 21 CFR Part 1 Subpart H

To designate a legally compliant U.S. Agent contact for a foreign food facility registered with the U.S. Food and Drug Administration (FDA), enabling the FDA to communicate with the facility as required under Section 415 of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 1 Subpart H. This service fulfills the statutory U.S. Agent contact requirement only. It does not transfer regulatory responsibility, operational control, or compliance obligations to the U.S. Agent.

Scope of Work

U.S. Agent Designation

Serve as the official FDA U.S. Agent contact for the foreign facility within FDA Industry Systems (FIS), including confirmation of agent acceptance during registration or registration updates. Provide official U.S. Agent contact details (address, telephone, and email) required for FDA Food Facility Registration records.

FDA Communication Handling

Receive FDA communications directed to the U.S. Agent, including:

Inspection notifications
Regulatory inquiries
Notices of action
Emergency communications

All communications are forwarded to the facility promptly without regulatory interpretation, legal analysis, or advisory opinion.

Emergency and Inspection Coordination

When the FDA initiates contact involving public-health or inspection-related matters:

Notify the facility contact
Act as a communication relay point
Facilitate communication routing between FDA and facility

Note: The U.S. Agent does not create facility responses to FDA on behalf of the facility unless separately authorized in writing.

Limited Remote Support

Includes up to two (2) hours per year of remote administrative support for:

Clarification of received FDA communications
Coordination calls or correspondence routing
Contact/response facilitation with FDA offices

FDA Registration Update and Renewal Assistance

As part of an active annual U.S. Agent subscription, administrative assistance may be provided for FDA Food Facility Registration updates and biennial renewals, including:

Collection of registration information required for updates or renewals
Facilitation of registration updates through FDA Industry Systems (FIS)
Facilitation of biennial FDA Food Facility Registration renewals
Confirmation of submission activities, where applicable

Registration update and renewal assistance is performed using information provided by the facility and may require the facility to grant access or authorization necessary to complete the requested activities.

Service Limitations

U.S. Agent services are strictly representational and communicative.

The service does NOT include:

Regulatory consulting or legal advice
Preparing FDA responses, corrective actions, or submissions
Acting as Importer of Record (IOR)
Acting as FSVP Importer, FSVP Agent, FSVP Qualified Individual, or PCQI
Compliance program implementation or document development
Guarantee of FDA approval, admissibility, or inspection outcome

The foreign facility remains fully responsible for regulatory compliance and responding to FDA findings.

Client Responsibilities

The facility must:

Maintain accurate FDA registration information
Respond to FDA communications in a timely manner
Provide updated contact details and operational changes
Maintain compliance with all applicable FDA regulations

Failure to respond to information requests within 10 business days may result in service suspension.

U.S. Agent Designation and Registration Maintenance

Act as the official U.S. Agent for the foreign facility, facilitating FDA Food Facility Registration (FFR) compliance under 21 CFR 1.232(d). Includes initial registration, biennial renewal, and ongoing updates to ensure facility status remains current and compliant.

Regulatory Communications Handling

Receive, review, and respond to communications from the FDA on behalf of the foreign facility, including inspection notices, detention alerts, import holds, facility verification requests, and official correspondence. Immediate escalation to facility contacts for time-sensitive regulatory actions.

Inspection and Detention Support

Coordinate and assist in FDA inspections, detention hearings, and regulatory investigations as needed. Provide guidance on inspection readiness, documentation requests, and required corrective actions following FDA inquiries.

FSVP Importer Coordination (Optional Add-On)

Facilitate coordination with designated U.S. FSVP Importers for foreign suppliers to streamline FSVP compliance under 21 CFR 1.500–1.514, including communication of supplier compliance status and documentation flow.

Emergency Response and Recall Notifications

Serve as the official contact for the FDA in the event of an emergency involving a recall, product contamination, or foodborne illness outbreak. Immediate notification to facility contacts and support for regulatory reporting obligations under 21 USC 381 and 393.

Recordkeeping and Documentation Support

Maintain internal records to support food facility registration tracking, communications logs, and regulatory response histories. Provide annual summaries of FDA communications and compliance activities related to the facility.

Deliverables

U.S. Agent Representation

Confirmation of U.S. Agent acceptance in FDA registration
Official U.S. Agent contact information for FDA records

Communication Relay

Forwarding of FDA correspondence to facility contacts
Notification of time-sensitive communications

Coordination Support

Communication routing during inspections or emergencies
Up to 2 hours annual remote support assistance

U.S. Agent Representation Package

• Official designation as the U.S. Agent on the FDA Food Facility Registration (FFR).
• Confirmation letters and facility authorization documentation.
• Ongoing FDA FFR management and biennial renewal support.

Regulatory Communications Management

• Receipt, translation (if needed), and forwarding of all official FDA communications.
• Escalation of critical notifications within 24 hours of receipt.
• Documentation of communication history for audit readiness.

Inspection and Incident Support

• Pre-inspection readiness checklist.
• Guidance during FDA facility inspections and detentions.
• Incident and recall coordination communications.

Recordkeeping Compliance

• FDA communications tracking logs.
• Registration change logs and renewal confirmation records.

Optional: FSVP Importer Compliance Support (Add-On)

• Coordination support between foreign facility and U.S. FSVP Importer.
• Documentation templates for Written Assurance and Supplier Compliance Declarations.

Fees and Subscriptions

Standard U.S. Agent Service — $199 USD per year per facility
Includes:

FDA U.S. Agent designation
FDA communication forwarding
Emergency contact coordination
Up to 2 hours annual support

Services begin after payment and remain active for a 12-month term.
Fees are prepaid and non-refundable.

Standard U.S. Agent Package – $199 USD / year per facility
Includes:
• U.S. Agent designation and biennial registration renewal
• Management of FDA communications
• Inspection and emergency response support
• Annual communication summary report

Add-Ons

• FSVP Importer Coordination Support: +$450/year
• Emergency Recall Notification and FDA Liaison Service (Event-Based): +$1450/event
• Additional Facility Registration Management: +$300/facility/year

Ideal For:

Foreign food manufacturers, processors, packers, or storage facilities that:

Maintain or require an FDA Food Facility Registration
Need a compliant U.S. Agent contact for FDA communications
Already manage their own FDA compliance or use separate consulting services

Foreign food manufacturers, processors, packers, and holders who are:
• Registering with the U.S. FDA under the Food Facility Registration (FFR) requirement.
• Exporting FDA-regulated food products to the United States.
• Seeking professional, full-service U.S. Agent representation beyond mail-forwarding services.
• Requiring enhanced support for FSVP compliance, recalls, inspections, or emergencies.