U.S. Agent Services for Foreign Facilities
Compliance Program Implementation based on 21 CFR 1.232(d) and Related Requirements
To establish and maintain official U.S. Agent representation for foreign facilities exporting FDA-regulated food products to the United States, ensuring full compliance with applicable FDA regulations including 21 CFR 1.232(d), 1.500–1.514 (FSVP), and applicable sections of 21 USC 381 and 393.
Scope of Work
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 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.
• 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.
• 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.
• 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.
• 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.
• Documentation templates for Written Assurance and Supplier Compliance Declarations.
Fees and Subscriptions
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
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
• 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, 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.
• 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.