FSVPQI Monthly Implementation End-to-End Support Services

Ongoing Monthly Compliance Program Based on 21 CFR 1.500–1.514, 117, 121, and Related Requirements

This monthly support service provides continuous oversight by a Foreign Supplier Verification Program Qualified Individual (FSVPQI) to ensure full alignment with FDA’s FSVP regulations. Designed for U.S. brand owners importing directly or via co-manufacturers, the program covers recurring verification, documentation management, and regulatory monitoring, ensuring sustained compliance and audit readiness.

Scope of Work

FSVP Compliance Oversight

Maintain and update the FSVP Program as needed, including reviewing supplier, product, and shipment records. • Monitor compliance with 21 CFR 1.500–1.514 • Make updates based on supplier/product changes or new risks

Supplier Qualification and Reassessment

Evaluate new suppliers and reassess existing ones per FDA guidance. • Monthly review of supplier risk status and documentation (certificates, food safety plans, audit summaries) • Flag and document any suppliers due for reassessment (every 3 years or as needed) • Update supplier risk matrix and contact logs

Verification of Controls

Review verification activities for all active suppliers and products. • Monthly review of COAs, third-party certifications, and historical performance • Identify gaps and initiate follow-ups for documentation completion

Product Hazard Analysis Review

Conduct and update product-specific hazard analysis and verification strategies. • Confirm existing controls remain valid or identify new risks • Document changes using FDA-aligned templates

Shipment Entry Verification & Documentation

Verify shipments against approved FSVP records. • Review CBP and FDA entry data (entry number, product code, manufacturer ID) • Match against supplier and product approvals • Log entry verification activities and traceability documentation

Label Identity and Entry Compliance Monitoring

Review new or updated labels to ensure 21 CFR 101.3 compliance. • Monitor labels for accurate identity statements, origin claims, and importer details • Verify label data matches entry records and supplier documentation

Traceability & Recordkeeping Updates

Maintain shipment-level traceability records. • Record BOLs, invoices, packing lists, COAs • Ensure proper linkage to product and supplier files • Maintain version-controlled records

Corrective Actions & Safety Event Review

Track and address non-conformance or adverse event reports. • Maintain incident logs • Generate Corrective Action Preventive Action (CAPA) reports as needed • Communicate updates and action steps

FDA Regulatory Monitoring

Weekly review of FDA import alerts, enforcement actions, and recalls. • Update supplier profiles if associated with an alert • Adjust verification frequency if risk increases

Ongoing SOP Support & Document Control

Update SOPs, logs, and templates based on monthly findings and client feedback. • Incorporate revisions for new processes, changes in supplier status, or regulatory shifts

Client Engagement & Reporting

Monthly progress reports and live updates. • Monthly client check-ins (email or video call) • Delivery of summary dashboard with key updates, deadlines, and action items

Deliverables

• Supplier Risk Evaluations & Approvals • Product Hazard Analysis Updates • Shipment Entry Review Logs • COA Verification and Product Specifications • Corrective Action and Safety Incident Logs • Version-Controlled SOPs and Documentation • Label and Entry Compliance Reports • Traceability Logs • Monthly Client Summary Report • Regulatory Watchlist Summary (FDA Alerts & Recalls)

Fees and Subscriptions

Plan	Number of Suppliers	Monthly Fee
Starter Plan	Up to 5 Suppliers	$799.00/month
Growth Plan	Up to 10 Suppliers	$1,195.00/month
Scale Plan	Up to 20 Suppliers	$2,150.00/month
Enterprise Plan	21+ Suppliers	Custom Quote

Includes in Every Plan:

• Monthly Supplier Risk Review and FSVPQI Approval • Monthly Product Hazard Analysis and Verification Plan Updates • Entry and Label Review for Incoming Shipments • Shipment Verification Documentation and Traceability Logs • CAPA Documentation and Adverse Event Monitoring • FDA Regulatory Monitoring and Response Actions • Monthly SOP and Template Revisions • Monthly Client Report and Coordination Meeting

Annual Maintenance Add-On – $2,400 USD / year

Includes:

• Annual Review and Archive of Supplier/Product Files • Annual Regulatory Compliance Check • Documentation Format Update for FDA Audit Readiness • Two (2) Online Refresher Training Modules

Add-Ons:

• Additional Supplier Setup: +$250/supplier • Additional Product Line Setup: +$150/product • Label Compliance Review (New Product): $750/label • Traceability Record Setup (FSVP High-Risk Foods): $300/setup • Live Staff Training (Zoom, 1 Hour): $250/session

Ideal For:

U.S.-based brand owners requiring monthly compliance oversight for foreign suppliers and imported food products. Designed for importers seeking to maintain continuous compliance with FSVP regulations and FDA readiness under the support of a designated Qualified Individual.