FSVPQI Implementation Support Services
Program Execution Based on 21 CFR 1.500–1.514 and Qualified Individual Responsibilities under FSMA Service Fee: Starting at $749 per Supplier / $199 per Product / Custom per Shipment Support
To implement and maintain a Foreign Supplier Verification Program under the oversight of a Qualified Individual (FSVPQI), this service provides structured activities tailored to importer needs. It ensures compliance with FDA’s FSMA requirements through supplier risk evaluations, product hazard analysis, shipment verification, and compliant recordkeeping systems—all aligned with the expectations of 21 CFR 1.500–1.514.
Scope of Work
Supplier Qualification and Approval
Qualify each foreign supplier through risk-based review of food safety systems, performance history, and compliance status:
- • Conduct initial approval and reevaluation every 3 years or as needed
- • Review third-party audits, food safety plans, FDA import alerts, and inspection history
- • Maintain supplier files including communications, COAs, and documentation
- • Reviewed annually or upon new supplier engagement
Product Hazard Analysis and Control Determination
Conduct product-specific hazard analysis to identify biological, chemical, and physical risks:
- • Determine control requirements and verification method per product
- • Review supplier documentation, product specifications, COAs, testing results, and audit findings
- • Maintain product-specific verification plans and reassessment logs
- • Conducted prior to import and updated with any formulation or supplier change
Shipment-Level Verification
Verify that each shipment aligns with FSVP-approved supplier and product criteria:
- • Match product identifiers, labels, and lot codes
- • Review COAs, entry data, packing lists, and traceability documentation
- • Validate FDA entry and ensure correct FSVP Importer designation
- • Record verification activities and adverse events
- • Performed for every shipment
Adverse Events and Corrective Action Review
Monitor safety incidents, complaints, or enforcement updates:
- • Maintain logs of FDA recalls and enforcement reports
- • Trigger corrective actions and CAPA processes when needed
- • Reviewed as events arise
FSVP Recordkeeping and Documentation Management
Maintain accessible, version-controlled documentation for FDA audit readiness:
- • File shipment verification logs, product reviews, supplier evaluations
- • Maintain 2-year retention as required under 21 CFR 1.512
- • Records updated continuously
Deliverables
Per Supplier
- • Supplier Approval Form
- • Risk-Based Supplier Evaluation
- • Supplier Communication Records
- • Supplier Verification Audit Reports
- • Corrective Action Reports (as applicable)
Per Product
- • Hazard Analysis for Products
- • Hazard Control Determination Statement
- • Verification Method Plan (Audit/Testing/Records)
- • Product COA Template or Specifications Sheet
- • Reassessment Summary
- • Product Recall & Safety Incidents Log
Per Shipment
- • Shipment Entry Verification Documentation
Fees and Subscriptions
| Service | Fee | Frequency |
|---|---|---|
| Initial and Annual FSVP Assessment for 1 supplier, 1 product, and 1 shipment | $499.00 | Annual |
| Additional products | $149.00 per product | Annual |
| Additional shipment | $149.00 | Per Shipment |
Ideal For:
U.S.-based importers needing Qualified Individual led FSVP implementation support to fulfill their responsibilities under FSMA. Especially valuable for importers managing multiple suppliers, high-risk products, or FDA-regulated goods such as processed foods, ingredients, and dietary supplements.