FSVP Requirements Compliance Management Set-Up for Brand Owners
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 for a Brand Owner to ensure 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 a customized FSVP policy and documentation structure for brand owners defined as FSVP importers.
This includes the creation of program documentation, procedures, and ongoing verification workflows. This program is established during the initial set-up phase and reviewed annually for regulatory alignment and updates.
Supply Chain Program Assessment
Develop SOPs for approval, monitoring, and re-evaluation of supplier (local and/or foreign), tailored to the client’s current processes. Perform full assessment of the supplier’s documentation as part of verification and approval, and set up a supplier evaluation checklist and status tracker.
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
Establish and manage product specifications for raw materials, in-process materials (WIP), packaging, labeling, and finished goods in line with 21 CFR 117.475. These specifications are reviewed quarterly to ensure consistency and compliance.
Food Defense / Intentional Adulteration Mitigation Strategies
Perform vulnerability assessments and identify actionable process steps and mitigation strategies according to 21 CFR 121.126 to 121.135. This food defense protocol is reviewed and updated annually or immediately after an incident or process change.
Recall Plan Development and Effectiveness Checks
Develop and maintain a detailed recall plan that includes notification procedures, effectiveness checks, and proper disposal methods as per 21 CFR 117.139. The plan is reviewed annually and tested semi-annually to ensure it remains functional and effective.
Label Identity Compliance
Develop SOPs and checklists to manage compliance monitoring and revisions of product labels, packaging specs, and supporting artwork.
Record Retention & Documentation Control
Set up SOPs and filing system guidance for creation, retention, and archiving of records and documentation, including document control logs and record access control guidance tailored to the client’s current processes.
Written Assurance Management
Draft written assurance agreements with contract manufacturers, co-manufacturers, and suppliers to confirm the implementation of supply-chain-applied controls. This is required under 21 CFR 117.335 and must be updated for each new agreement or annually.
Traceability Plan Development and Maintenance
Establish traceability records for high-risk food products in compliance with 21 CFR 1.1315. This includes recordkeeping systems, traceability plan components, and food establishment responsibilities. The plan is reviewed annually or when new covered products are introduced.
Food Safety/HACCP Plan
Develop templates covering the elements of the food safety plan, such as hazard identification, flow diagram, critical control points and preventive control identification/monitoring, and corrective action logs.
Emergency Response & Food Security Strategy
Create and maintain a food safety and crisis response plan to address events such as recalls, contamination, and intentional adulteration, as required by 21 USC 301. This plan is reviewed annually to ensure readiness and compliance.
SOP Development, Customization & Client Engagement
Develop standard operating procedures (SOPs), policies, and forms with customized branding, formatting, and document control per internal SOP standards. Engage the client for feedback and revisions. This process is performed during initial implementation and updated as required.
Training and Capacity Building
Develop training materials and deliver training sessions covering FSVP responsibilities, supplier verification, hazard identification, food defense, and documentation protocols. Training is provided quarterly or during onboarding of new personnel, following the guidelines of 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 the following: Foreign Supplier Verification SOPs, Supplier Audit Procedures, Risk Analysis Matrix, Product Specification Templates, Food Defense SOPs, Recall SOPs, HACCP/Food Safety Plan, Written Assurance Forms, and Traceability Forms.
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
Covers critical documentation control, including Documentation Logs, Version-Controlled Record Indexes, and Annual Review Checklists to ensure traceability and accountability.
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 Evaluations 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
Client engagement tools include SOP Client Presentation Decks, Meeting Summaries, and Change Request Logs to facilitate collaboration and feedback throughout the implementation process.
Fees and Subscriptions
Standard Compliance Package – $5,950 USD (One-Time Set-Up Fee)
Includes:
• Documentation review of up to 1 Supplier and 1 product • Drafting of SOPs, Policies, Checklists, and Compliance Forms • Food Defense (IA Rule) Vulnerability Assessment & Mitigation Strategy • Recall Plan Preparation with Effectiveness Checks • HACCP / Food Safety Plan (117.126/120.8) • Written Assurance Agreements with Co-Manufacturers/Suppliers • Product Label Compliance Assessment Review Forms • Traceability Plan Setup (1.1315) • Internal Review, Revisions, and Approval Formatting • Client Engagement Meetings & Email Support
Annual Maintenance Package – $2,400 USD / year
Includes:
Add-Ons:
Ideal For:
U.S.-based importers, brand owners, or co-packers seeking to establish or upgrade a fully compliant FSVP system tailored to FDA expectations and audit-readiness.