FSVPQI, FSVP Agent, and US Agent Comparison
FSVP Qualified Individual (FSVPQI)
The FSVPQI is the person with the education, training, or experience (or combination thereof) to perform FSVP activities. Their role is hands-on with compliance.
Key Activities:
- • Serve as the importer’s official point of contact with FDA for FSVP compliance.
- • Review and assess supplier compliance with U.S. food safety regulations (e.g., hazard analysis, preventive controls, allergen controls).
- • Evaluate supplier performance and risk (food safety history, regulatory history, audits, certificates).
- • Approve suppliers based on risk assessment.
- • Establish, implement, and maintain written FSVP procedures.
- • Review and approve corrective actions when non-conformances or violations occur.
- • Review, sign, and maintain FSVP records.
- • Conduct periodic reassessments of suppliers at least annually or when changes occur.
- • Ensure proper documentation for each imported food product.
- • Train and guide internal teams on FSVP requirements.
- • Ensure record availability during FDA inspections.
Deliverables may include:
- • FSVP program review and signature
- • FSVP records review confirmation
- • FSVP Compliance reports
- • Hazard analyses
- • Supplier approval and verification activity records records
- • Centralized FSVP documentation repository
- • Written FSVP procedures
- • Corrective action documentation
- • Supplier reassessment reports
- • Documentation submission logs for FDA-initiated requests
FSVP Agent
The FSVP Agent is a U.S.-based entity responsible for maintaining the FSVP on behalf of a foreign supplier and may implement supplier verifications to help them ensure compliance. For importers, an FSVP Agent may ensure that they have developed FSVP programs, and may represent the entity for FDA communications. While the U.S. regulations define no specific role for an FSVP Agent, most food facilities overlap the FSVP Agent role with the FSVPQI but is more organizational and representative.
Key Activities:
- • Serve as the importer’s official point of contact with FDA for FSVP compliance.
- • Review FSVP documentation and records for each product (if designated by foreign supplier).
- • Ensure FSVP programs are implemented for each food/product category (if designated by importer).
- • Ensure that the entity has FSVP procedures that are developed for approving and verifying suppliers (if designated by importer).
- • Submit FSVP records to FDA upon request.
- • Respond to FDA communications regarding FSVP (e.g., inspection requests, Form 483 responses).
- • Review corrective actions with suppliers when risks are identified.
Deliverables may include:
- • Agent designation letter
- • Communication logs
- • Documentation submission logs for FDA-initiated requests
- • FSVP program review confirmation (for importers)
- • FSVP implementation checklists
- • Supplier verification report (for foreign entities)
U.S. Agent
The U.S. Agent is required for foreign facilities under FDA’s Food Facility Registration (FFR) requirements, and may sometimes overlap with the FSVP Agent, but they are not automatically the same. Their role is more administrative and communication-focused.
Key Activities:
- • Serve as the domestic contact for FDA on behalf of the foreign food facility.
- • Receive and respond to FDA communications regarding the foreign facility (registration, inspections, recalls, enforcement).
- • Remind the facility of any food facility registration renewals and updates, and provide updated contact information for US agent designation.
- • Relay FDA communications promptly to the foreign facility.
- • Be available for FDA during emergencies or regulatory inquiries on the foreign entity.
- • Assist with coordination during FDA inspections of the foreign facility.
- • Maintain contact details in the FDA registration system and update when needed.
Deliverables may include:
- • U.S. Agent designation letter
- • U.S. Agent information and periodic updates
- • FDA communication logs
- • FDA Registration renewal reminder notices
Summary of Distinction
FSVPQI
Technical expert ensuring compliance (hazard analysis, supplier verification and approval, program management), FSVP regulatory liaison, and representation.
FSVP Agent
U.S.-based entity capable of oversight of FSVP program implementation and interacting with FDA
U.S. Agent
U.S.-based contact required for facility registration and FDA communications, not necessarily handling FSVP.
Comparison Table: FSVPQI vs. FSVP Agent vs. U.S. Agent Activities
| Frequency | FSVPQI (Technical Expert) | FSVP Agent (FSVP Oversight) | U.S. Agent (FDA Communications) |
|---|---|---|---|
| Daily |
• Monitor FDA communications • Relay FDA inquiries to foreign facility • Review shipment documents (COAs, lab results, BOLs) • Verify supplier records • Identify hazards/non-conformances • Communicate corrective actions • Sign and file records |
• Receive and file shipment documents • Respond to FDA questions • Monitor FDA Import Alerts/recalls |
• Monitor FDA communications • Relay FDA inquiries to foreign facility • Respond to urgent FDA contacts • Keep contact available to FDA |
| Weekly |
• Review supplier updates and recalls • Monitor FDA enforcement actions • Follow up on corrective actions • Verify weekly shipment documentation |
• Monitor FDA notices • Update compliance dashboards • Ensure contact accessibility |
• Check FDA notices or system updates • Ensure contact accessibility • Maintain communication log |
| Monthly |
• Audit supplier documentation • Review FDA policy updates • Check for recalls or warning letters • Share updates with facility |
• Update supplier risk assessments • Verify supplier approval list • Provide training materials on FSVP procedures • Perform documentation checks • Coordinate with FSVPQI on supplier evaluations |
• Confirm registration/contact info • Review FDA policy updates • Check for recalls or warning letters • Share updates with facility |
| Quarterly |
• Conduct supplier performance reviews • Verify supplier monitoring activities • Prepare compliance summary reports |
• Ensure FSVP procedures are followed • Verify corrective action closures (if applicable) |
• Verify FDA registration details • Check FDA communications were addressed |
| Biannual |
• FSVP supplier/shipment records review (if applicable) • Supplier/importer compliance meetings |
• Provide insights on any regulatory updates on FSVP | • Coordinate meetings with foreign facility (if applicable) |
| Annual |
• Update hazard analyses • Reassess and approve suppliers • Update FSVP written procedures • Verify recordkeeping compliance • Deliver annual compliance report |
• Review FSVP procedures • Deliver annual FSVP compliance report • Update importer documentation • Confirm record retention compliance |
• Send reminder for FDA Food Facility Registration renewal (biennial) • Provide annual communication summary • Update agent designation if needed |
| As Needed |
• Facilitate communication with FDA upon notice of FSVP inspection • Address any FDA-related inquiries |
• Facilitate USDA import permit renewals | • Facilitate communication with FDA upon notice of FSVP inspection |
