FSVP Agent Representation for Foreign Suppliers
FSVP Importer of Record Designation Based on 21 CFR 1.500–1.514
To provide full-service U.S.-based FSVP Agent Representation in compliance with the Foreign Supplier Verification Program (FSVP) regulations under 21 CFR Part 1 Subpart L for foreign suppliers of food, beverages, and dietary supplements who do not have a U.S. importer or owner at the time of entry.
Scope of Work
FSVP Importer Designation
- Act as the designated FSVP importer/agent for purposes of Customs entry and FDA compliance, using UFI (DUNS) and email address as required by 21 CFR 1.509(a). Includes issuance of formal agent designation letters for each facility or shipment as needed.
FDA Communications Point-of-Contact
- Serve as the official contact for FDA inspections, record requests, recalls, safety alerts, and enforcement notices. Maintain updated contact credentials with CBP and FDA to support proper entry declaration.
Entry Line Review & Prior Notice Verification
- Review food entry lines into the U.S. to ensure accuracy in importer declarations, match FSVP agent data with CBP filings, and optionally file Prior Notice if selected as an add-on.
Supplier Document Intake and Screening
- Provide document submission templates to foreign suppliers and conduct a basic intake review of HACCP plans, food facility registration, and product specifications. Store key documents in InterlinkIQ™ or equivalent system.
Recall Alert Handling and Notification
- Coordinate notifications in the event of recalls, FDA import alerts, or facility concerns. Notify foreign supplier and provide guidance on next steps per 21 CFR 117.139 obligations.
Annual Compliance Review
- Conduct an annual internal review of FSVP Agent activities and supplier documents to support continued designation eligibility and ongoing FDA audit readiness.
Deliverables
• AFSVP Agent Designation Letter (per supplier/facility)
• Entry Filing Information Packet (UFI, importer name, contact)
• Basic Document Intake Review Checklist
• Recall Communication Logs
• Annual Activity Report Summary
• Live Support During FDA Inquiries or Inspections
• Optional Digital Compliance Folder in InterlinkIQ
Fees and Subscriptions
| Package | Fee | Description | Action |
|---|---|---|---|
| Basic Agent Service | $199/year | For small exporters or low-volume importers; includes designation letter and FDA contact | Subscribe |
| Agent + Compliance Oversight | $499/year | Adds entry monitoring, annual review, and digital documentation | Subscribe |
| Agent + Full FSVP Setup | Custom Quote | Combines agent role with full program creation under 21 CFR 1.500–1.514 and 117 Subpart G | Subscribe |
Add-Ons:
- • Prior Notice Filing – $39/shipment
- • FDA Registration Assistance – $149/facility
- • Compliance Folder (InterlinkIQ Setup) – $250 one-time
Ideal For:
- • Foreign suppliers of human food, dietary supplements, beverages, and ingredients
- • Exporters shipping to the U.S. without a U.S.-based importer or business entity
- • Contract manufacturers, brand exporters, or bulk processors selling into the U.S. market
Service Activation Timeline
- • 48 Hours or less upon receipt of completed onboarding form and payment
- • Emergency Agent Activation Available for time-sensitive shipments
Regulatory References
- • 21 CFR 1.500–1.514 – Foreign Supplier Verification Program
- • 21 CFR 117 Subpart G – Supply Chain Program Requirements
- • 21 CFR 117.139 – Recall Plan Requirements
- • 21 CFR 1.509 – Import Entry Requirements
- • FDA Guidance for Industry: FSVP for Importers of Food for Humans and Animals