FSVPQI End-to-End Monthly Remote Supplier Compliance Management Subscription
Compliance Program Implementation based on 21 CFR 1.500–1.514, 117, 121, and Related Requirements
To establish and maintain an ongoing Foreign Supplier Verification Program Qualified Individual (FSVPQI) End-to-End Compliance Management System for Importers and Brand Owners to ensure full continuous compliance with 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 Remote Compliance Program
Provide continuous development, implementation, maintenance, and updating of a Foreign Supplier Verification Program (FSVP) in accordance with 21 CFR 1.500–1.514. This includes document verification, corrective action workflows, supplier monitoring, and periodic updates to verification plans based on risk.
Supply Chain Program Assessment
Perform ongoing remote supplier risk assessments and raw material evaluations in accordance with 21 CFR 117.405 to 117.430. Risk reassessments are conducted annually, upon the addition of new suppliers, and/or whenever changes occur.
FSVPQI Remote Supplier Verification Assessment
Conduct remote, risk-based routine supplier verifications according to 21 CFR 117.435, including food safety documentation reviews. Findings are documented in verification reports with required corrective actions.
Ongoing Supplier Monitoring and Compliance Tracking
Monitor suppliers for regulatory alerts, recalls, certifications changes, and incidents monthly. Provide routine compliance updates and proactively adjust verification activities as necessary based on supplier status and risk.
Corrective Action Management
Manage supplier corrective actions following verification findings, including assessment of corrective actions taken and issuance of closure reports to maintain compliance records.
Risk-Based Verification Plan Management
Continuously update and manage importer-specific risk-based verification plans to ensure supplier activities align with regulatory expectations based on product, country of origin, and known risks.
Record Retention and Documentation Control
Maintain all FSVP-required records, with monthly documentation updates and version control, ensuring full compliance with 21 CFR 117.315 and 117.430 requirements.
FDA Inspection Readiness Support
Support clients during FDA inspections by preparing required FSVP records, providing remote support during FDA audits (if applicable), and assisting in audit responses.
Virtual Training and Capacity Building
Periodically provide remote training materials on FSVP regulatory requirements, supplier verification protocols, hazard identification, documentation standards, and corrective action management for client teams.
Deliverables
• Supplier Verification Reports (initial and annual updates)
• Corrective Action Reports and Closure Confirmations
• Risk-Based Verification Plans
• Compliance Monitoring Reports
• Supplier Monitoring Status Summaries
• FDA Inspection Preparation Checklists
• FSVP Activities Training Materials
Fees and Subscriptions
Subscription Options:
| Service Tier | Coverage | Fee | Action |
|---|---|---|---|
| FSVP Importer Toolkit | Foreign Supplier Verification Program (FSVP) Toolkit Setup | $1,550 (one-time) | Purchase |
| End-to-end FSVPQI Support | from 50 monthly support hours | starts at $1,000 per month | |
| FSVPQI Services On-demand | varies | $12/hour |
Monthly Subscription Inclusions:
• FSVP Remote Compliance Management
• Supplier Verification and Monitoring
• Risk Plan Updates and Management
• Corrective Action Review and Tracking
• FSVP Training for Staff
• FDA Inspection Remote Support
• Recordkeeping and Documentation Updates
Ideal For:
• U.S. importers, brand owners, U.S. agents, and co-packers requiring continuous, fully remote, subscription-based FSVP compliance management to stay inspection-ready and maintain supplier compliance without hiring full-time internal FSVP staff.
