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 (if applicable)

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 (if applicable)

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 (if applicable)

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 (if applicable)

Periodically provide remote training materials on FSVP regulatory requirements, supplier verification protocols, hazard identification, documentation standards, and corrective action management for client teams.

Support Options

FSVP Full Compliance Program and FDA Inspection Readiness - One-Time Setup

First supplier – $900 (one-time fee) Each additional supplier – $450 (one-time fee) This setup-only program provides a complete, FDA-compliant FSVP file for each supplier and prepares the importer for a full FDA FSVP inspection. Designed for companies that want a turnkey, fully documented FSVP program without monthly service commitments. Includes: • Full development of FSVP files for each supplier • Comprehensive hazard analysis per supplier and per product • Supplier approval documentation and evaluation of food safety controls • Verification plan development and verification scheduling • Review and organization of supplier evidence (COAs, audits, specs, allergen info, etc.) • Product-level documentation setup for all items imported from each supplier • Importer responsibility documentation and FSVP recordkeeping system Preparation for FDA FSVP inspections, including: • Mock inspection walkthrough • Documentation readiness review • Corrective action recommendations • Digital organization of all required FSVP documentation for easy FDA retrieval (Add-on) Additional Suppliers: $450 per additional supplier (one-time fee) (Add-on) Additional Products / Materials per Supplier: $175 per additional product (one-time fee) FDA requires verification per supplier–product combination, meaning each product must have its own hazard analysis and verification documentation. Covers: • Product-specific hazard analysis • Verification plan creation • Review of COAs, specifications, allergen declarations, etc. • Product-level documentation and compliance file setup • Product-level FSVP recordkeeping requirements

FSVP Maintenance and Monthly Compliance Support

Includes: • Routine updates and maintenance of FSVP files (up to 15 suppliers) • Monthly advisory support and FDA regulatory guidance • Supplier document management and verification tracking • Troubleshooting of shipment, supplier, or documentation issues • Monitoring corrective actions and verification due dates • Maintenance of product-level documentation and verification requirements (Add-on) Additional Suppliers: $90/month per additional supplier (Add-on) Additional Products / Materials per Supplier: $45/month per additional product FSVP verification is conducted per supplier–product combination, meaning each product requires its own hazard analysis and verification tracking. This covers: • Product-specific verification tracking • Document updates (COAs, specifications, allergen info, etc.) • Product-level risk monitoring and recordkeeping • Maintenance of product-level FSVP requirements

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 Summary

Subscription Options:

Service Tier	Remarks	Fee
FSVP Importer Toolkit	Foreign Supplier Verification Program (FSVP) Toolkit Setup (templates only)	$1,550 (one-time)
FSVP Importer Compliance Set-up	This setup-only program provides a complete, FDA-compliant FSVP file for each supplier and prepares the importer for a full FDA FSVP inspection. Designed for companies that want a turnkey, fully documented FSVP program without monthly service commitments.	$900 per supplier (one-time) $450 per additional supplier $175 per additional product
FSVP Maintenance and Monthly Compliance Support - up to 15 suppliers	Designed for importers who require ongoing maintenance and routine updates to their existing FSVP Program.	Up to 15 suppliers: $1,550/month $90/month per additional supplier
FSVP Maintenance and Monthly Compliance Support - Additional Products/Materials per Supplier	FDA requires FSVP verification per supplier–product combination, meaning each product requires its own hazard analysis and verification tracking. Covers product-specific verification tracking, document updates (COAs, specifications, allergen info, etc.), product-level risk monitoring and recordkeeping, and maintenance of product-level FSVP requirements.	$45/month per additional product (applies when a supplier provides multiple products, SKUs, or materials)

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.