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FSVP and FFVA Annual Supplier Compliance Assessment Services

Annual Supplier Oversight Program Based on 21 CFR 1.500–1.514, GFSI Benchmarks, and Food Fraud Risk Assessment Standards

To maintain a secure and compliant supply chain, this service delivers a comprehensive annual assessment and documentation program for domestic and foreign suppliers. Designed to support FDA FSVP compliance, food fraud vulnerability mitigation, and supplier approval programs, this framework ensures traceability, regulatory alignment, and audit readiness across your supply base.

Scope of Work

Annual Supplier Requirements Assessment

Conduct a detailed annual review of supplier performance and documentation.
  • • Review COAs, third-party certifications, and compliance documents
  • • Evaluate supplier history, performance trends, and non-conformances
  • • Maintain organized, traceable supplier records
  • • Frequency:
    • - Annually per supplier
  • • Included in $249/supplier fee

Supplier Approval Program (SAP) Annual Review

Evaluate and maintain a risk-based Supplier Approval Program in compliance with industry best practices.
  • • Confirm supplier qualifications through audit summaries and certification reviews
  • • Update supplier approval statuses and approval matrix
  • • Maintain a secure, searchable supplier database
  • • Frequency:
    • - Annually
  • • Included in $249/supplier fee

Foreign Supplier Verification Program (FSVP) Compliance Review

Verify that foreign suppliers meet FSVP requirements under 21 CFR 1.500–1.514.
  • • Maintain current list of FSVP-regulated foreign suppliers
  • • Review audit reports, lab testing results, and inspection records
  • • Identify risk categories and draft corrective action plans, if needed
  • • Monitor FDA import alerts and supplier warning letters
  • • Frequency:
    • - Annually
  • • Included in $249/supplier fee

Food Fraud Vulnerability Assessment (FFVA) Review

Evaluate food fraud risks in the supply chain using GFSI-based vulnerability assessment methodology.
  • • Validate source documentation, ingredient traceability, and fraud mitigation controls
  • • Assign fraud risk levels and assess effectiveness of existing controls
  • • Frequency:
    • - Annually per supplier
  • • Included in $249/supplier fee

Product-Specific Compliance Review

Verify regulatory documentation for each product associated with suppliers.
  • • Review labeling compliance, specifications, allergen declarations, and certifications
  • • Frequency:
    • - Annually per product
  • • Included in $129/product fee

Deliverables

Annual Supplier Evaluation Reports

Summarizes each supplier’s performance and compliance status, identifying gaps and corrective actions taken.

Updated Supplier Compliance Records

Organized digital documentation of supplier certifications, COAs, performance logs, and review notes.

Supplier Approval Program (SAP) Compliance Report

Details supplier status in the approval matrix, including high/medium/low risk categorization and recommendations.

Foreign Supplier Verification Records

Complete documentation of foreign supplier verifications, risk assessments, and follow-up actions.

Food Fraud Vulnerability Assessment (FFVA) Summary Report

Includes fraud risk rating by supplier, validation of controls, and corrective action guidance.

Corrective Action Plans (If Applicable)

Written plans addressing non-conformances, incomplete records, or supplier performance concerns.

Compliance Guidance Tools

Checklists, templates, and tracking logs for internal use and ongoing supplier compliance monitoring.

FSVP Training Sessions (Optional)

Training materials and virtual sessions on FSVP, SAP, and FFVA compliance requirements.
  • • Add-On Fee:
    • +$250 per live virtual session (1 hour)

Fees and Subscriptions

Service Fee Frequency
Annual Supplier Compliance Assessment $249 per Supplier Annually
Annual Product Compliance Review $129 per Product Annually
Add-On: Live Staff Training $250 per Session As Needed

Ideal For:

U.S.-based importers, quality assurance teams, and supplier compliance managers seeking to maintain an FDA-compliant supply chain, proactively manage food fraud risks, and ensure suppliers meet documented performance and verification standards.

Get Started: Contact us at info@consultareinc.com or submit your request via our online form.