FSVP Requirements Compliance Management Set-Up for Exporters
FSVP Requirements Compliance Management Set-Up for Exporters
As a foreign food exporter, your products are subject to the Foreign Supplier Verification Program (FSVP) under the FDA Food Safety Modernization Act (FSMA) once they enter the U.S. market. While the legal responsibility lies with the U.S. importer, exporters that proactively align with FDA FSVP requirements gain a competitive edge by being audit-ready, reducing delays at the border, and increasing buyer trust.
Consultare Inc. Group provides an FSVP Compliance Management Set-Up for Exporters—designed to help manufacturers, brands, and co-packers outside the U.S. prepare documentation, risk assessments, and verification records aligned with U.S. FSVP requirements.
Scope of Work
FSVP Readiness Program
Develop and implement an FSVP-compliant documentation system tailored for foreign exporters, in alignment with 21 CFR 1.500–1.514. This includes recordkeeping, supplier verification support, and buyer assistance packages.
Supply Chain Risk Documentation
Prepare and organize risk analysis of raw materials and finished products, based on 21 CFR 117.405 to 117.430. Support your U.S. buyer's verification obligations.
Onsite/Remote Audit Preparation
Prepare audit-ready documentation, self-assessment templates, and third-party audit reports in line with 21 CFR 117.435 to support importer audit requirements.
Product Specification Management
Develop detailed specification sheets for raw, WIP, packaging, and finished goods in line with 21 CFR 117.475. Maintain version control and traceability.
Food Defense / Adulteration Risk Mitigation
Conduct a vulnerability assessment and build a mitigation strategy as outlined in 21 CFR 121.126–121.135. Support food defense compliance.
Recall and Crisis Documentation
Develop product recall SOPs and internal checklists in line with 21 CFR 117.139. Include exporter-buyer coordination roles for recalls or FDA actions.
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.
Traceability Plan Development
Document traceability procedures for high-risk products in accordance with 21 CFR 1.1315. Assist in building the Traceability Record Package.
Food Safety/HACCP Plan Alignment
Develop or align your HACCP/Food Safety Plan with 21 CFR 117.126 and 120.8 to meet buyer verification expectations under FSVP.
Written Assurance & Buyer Support Package
Provide a complete document set (written assurances, verification records, risk logs) that importers can use to fulfill their FSVP obligations.
Customized SOPs and Training Support
Create branded SOPs, policies, and forms that demonstrate your commitment to U.S. food safety. Optional staff training sessions are available.
Deliverables
FSVP-Ready Exporter 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:
• Exporter-Focused FSVP SOPs • Audit Templates and Risk Assessments • Product Specification Sheets • Food Defense and HACCP Documentation • Recall SOPs and Buyer Coordination Plan • Label Compliance Checklists • Written Assurance Templates
Training Package by TrainingAce.pro
Client Engagement Support
• Buyer Communication Decks • Document Submission Cover Letters • Engagement & Update Logs
Fees and Subscriptions
Standard Compliance Setup – $4,950 USD (One-Time)
Includes:
Annual Documentation Maintenance – $1,800 USD / year
Includes:
Add-Ons:
Ideal For:
Exporters of food, beverages, dietary supplements, ingredients, or co-packed goods looking to: • Enhance buyer confidence • Streamline U.S. market entry • Provide FSVP-compliant documentation • Minimize customs delays and FDA scrutiny