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 Qualified Individual (FSVPQI) Representation

Act as the FSVP qualified individual/agent for purposes of Customs entry and FDA compliance:
- • Serve as designated FSVP QI of record in the DUNS and FDA systems. • Review whether the foreign facility has established FSVP procedures and documentation. • Advise whether the current documentation meets general expectations for FDA import compliance. • Coordinate updates if the FDA sends any communication related to the FSVP designation.

U.S. Agent for FDA Communications

Act as the designated U.S. Agent/representative for the Foreign Entity under 21 CFR Part 1 Subpart H:
- • Maintain updated contact credentials with CBP and FDA to support proper entry declaration. • Serve as the primary point of contact with the FDA on behalf of the Foreign Entity. • Receive and promptly forward FDA communications (e.g., inspection notices, regulatory inquiries). • Maintain up-to-date contact information with the FDA for both the U.S. Agent and the Foreign Entity.

Entry Documentation Review & Prior Notice Verification (if applicable)

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 Documentation Review (if applicable)

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 systems (if applicable).

FDA/Regulatory Notifications and Alerts Coordination

Coordinate notifications in the event of recalls, FDA import alerts, or facility concerns, and provide guidance and insights based on regulatory requirements to support corrective action implementation.

Annual/Quarterly Compliance Review (if applicable)

Conduct an annual internal review of FSVP Agent activities and supplier documents to support continued designation eligibility and ongoing FDA audit readiness.

Deliverables

• FDA - U.S. Agent Designation for FDA Communications • FSVP - QI Contact Information (if applicable) • Review checklist for the following documentation (if applicable):

- FSVP Procedures - Hazard Analysis (HA) - Supplier Approval Procedures - Supplier Evaluation and Approval Records - Corrective Action Procedures and Records - Verification Activities - FSVP Reassessment Records - FSVP Recordkeeping Practices - Supplier Records

• FDA Communication Logs • Annual Activity Report Summary (if applicable) • Compliance Reminders and Regulatory Insights • Communications Support During FDA Inquiries or Inspections • Optional Digital Compliance Folder in InterlinkIQ (if with active software subscription)

Fees and Subscriptions

Package	Fee (USD)	Inclusions	Action
Basic U.S. Agent Service	$199/year	U.S. Agent representation (per facility) Up to 5 forwarded FDA email correspondences/forwardings per year (e.g., renewal reminders, suspension warnings, records requests, inspection notices, and compliance notifications) U.S. Agent contact information for FDA communications Annual confirmation of contact information	Subscribe
Basic U.S. Agent + FSVPQI Oversight	$749/year	All features in Basic U.S. Agent package; plus: Foreign Supplier Verification Program Qualified Individual (FSVPQI) designation FSVPQI and U.S. Agent contact information Annual review for FSVP procedures (with recommendations, if any) Documents Review Checklist for FSVPQI Activities FDA/Regulatory communications log, if any Dedicated email support (up to 10 correspondences/email forwardings per year) during FDA inquiries or inspections Guidance and notifications on regulatory changes Compliance reminders (e.g., FDA registration renewal, supplier reevaluations), if any Documentation review checklist for FSVPQI activities Digital FSVP Compliance Folder in InterlinkIQ (optional; if availed with software subscription)	Subscribe
End-to-end U.S. Agent + FSVPQI Oversight	Custom Quote	Everything in Basic U.S. Agent + FSVPQI Support, plus: Full FSVP Program and monitoring records development and customization (per 21 CFR 1.500–1.514 & 117 Subpart G) Remote FSVPQI activities, including initial/annual/quarterly supplier verification and FSVP implementation, reassessment, and updating Unlimited email forwarding for FDA/regulatory inquiries, inspection notices, complaints, records requests, or recalls Verification of shipment entry documents and Prior Notices	Subscribe

Add-Ons:

• Prior Notice Filing – $75 per product/shipment • FDA Food Facility Registration (initial) - $450 per facility

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