FSVP Requirements Compliance Management Set-Up for Importers
Compliance Program Implementation based on 21 CFR 1.500–1.514, 117, 121, and Related Requirements
To establish and maintain a comprehensive FSVP Compliance Management System specifically for U.S.-based Importers, ensuring full compliance with applicable FDA regulations including 21 CFR 117 (Subpart G), 121, 101.3, 1.1315, 117.139, 117.315, 117.435, 117.475, 117.335, 117.126, and 120.8, and applicable sections of 21 USC 301.
Scope of Work
FSVP Compliance Program
Develop, implement, and maintain a Foreign Supplier Verification Program (FSVP) in accordance with 21 CFR 1.500–1.514, specifically tailored for importer operations. Includes documentation, verification workflows, and recordkeeping systems. Reviewed annually.
Supply Chain Program Assessment
Conduct importer-led supply-chain risk assessments and evaluate verification activities, as outlined in 21 CFR 117.405 to 117.430. Conducted semi-annually or with each new supplier.
FSVPQI Remote Supplier Verification Assessment
Conducted in accordance with 21 CFR 117.435, this service provides risk-based remote assessments of foreign suppliers. It includes a review of food safety documentation, preventive controls, and optional virtual interviews. High-risk suppliers are assessed annually; moderate to low-risk suppliers biennially. A detailed verification report with corrective actions ensures compliance with FDA requirements—supporting regulatory readiness without the need for onsite audits.
Specification Program & Management
Define and manage product specifications for incoming shipments, raw materials, WIP, and finished goods under 21 CFR 117.475. Reviewed quarterly.
Food Defense / Intentional Adulteration Mitigation Strategies
Conduct vulnerability assessments and develop mitigation strategies per 21 CFR 121.126–121.135. Reviewed annually or post-incident.
Recall Plan Development and Effectiveness Checks
Develop importer-specific recall plans, including notification procedures and disposal protocols under 21 CFR 117.139. Tested semi-annually.
Label Identity Compliance
Ensure product labels meet FDA identity labeling requirements (21 CFR 101.3) for each product imported. Reviewed with each change or addition.
Record Retention & Documentation Control
Maintain traceable, version-controlled documents in line with 21 CFR 117.315 and 117.430. Updated monthly, audited annually.
Written Assurance Management
Draft and update written assurance agreements with foreign suppliers to confirm control responsibilities under 21 CFR 117.335.
Traceability Plan Development and Maintenance
Develop a traceability plan for high-risk foods as per 21 CFR 1.1315. Reviewed annually or with new covered product introductions.
Food Safety/HACCP Plan Verification
Review supplier HACCP or Food Safety Plans for FDA compliance under 21 CFR 117.126 and 120.8. Reviewed annually or post-incident.
Emergency Response & Food Security Strategy
Create importer-focused food safety and crisis management plans for recalls, contamination, or intentional adulteration, in compliance with 21 USC 301.
SOP Development & Client Engagement
Create customized SOPs and policies for importer responsibilities. Format, brand, and revise with client input. Maintained through feedback loops.
Training and Capacity Building
Provide training and awareness modules for importer teams on FSVP responsibilities, food defense, traceability, and documentation under 21 CFR 117.4 and 121.160.
Deliverables
FSVP Compliance Package
Includes a complete FSVP Program available in digital and/or print format. The package contains all required SOPs, company-specific policies, and verification forms essential for meeting FDA regulatory compliance requirements.
Customized SOPs & Compliance Documents
Includes:
Audit & Verification Reports
Comprehensive set of audit forms and training materials used for supplier verification and compliance evaluation. Includes Audit Templates and Reports, Supplier Evaluation Scorecards, and Food Safety Compliance Risk Logs to support regulatory readiness and continuous improvement.
Records Management
Comprehensive records tools including Logs, Version-Control Indexes, and Review Checklists.
Label Compliance Assessment
This service provides internal tools—not a regulatory review—for identifying labeling non-conformances and tracking revisions. It includes structured forms and assessment checklists such as Product Label Review Forms and 101.3 Identity Compliance Checklists, helping teams evaluate labels against FDA requirements and maintain accurate, up-to-date product information.
Training Package by TrainingAce.pro
Delivered through TrainingAce.pro, this package includes comprehensive training materials such as Presentation Decks, Quizzes, Evaluations, Attendance Logs, and Certificates. Designed to support internal training requirements and enhance staff awareness, these resources ensure consistent knowledge transfer and regulatory preparedness across teams.
Client Engagement Support
Presentation decks, meeting summaries, and change request logs to ensure alignment and feedback during implementation.
Fees and Subscriptions
Standard Compliance Package – $5,950 USD (One-Time Set-Up Fee)
Includes:
Annual Maintenance Package – $2,400 USD / year
Includes:
• Annual Review and Updates of FSVP Documents • Updated Risk Assessment Report • Version Control and Documentation Review
Add-Ons:
• Additional Supplier Setup: +$249/supplier • Additional Product Line Setup: +$149/product • Product Label Compliance Assessment Review (New Product): $150/Label • Traceability Setup for High-Risk Foods: $300/setup: $300/setup
Ideal For:
U.S.-based Importers seeking to establish, update, or maintain a fully compliant FSVP program in accordance with FDA expectations—especially those importing food and beverages, ingredients, dietary supplements, or packaged goods.