Supplier Identification & Risk Screening
A Foundational Component of Your FSVP Program
Published by FSVP SERVICES | A Service by Consultare Inc. Group – A Compliance Company
Under the FDA’s Foreign Supplier Verification Program (FSVP), U.S. importers must ensure all foreign suppliers operate with adequate preventive controls, verified processes, and documented food safety practices. The first and most critical step is Supplier Identification & Risk Screening—a structured method to evaluate supplier risk, determine required verification activities, and maintain compliance.
A robust supplier screening process helps importers confirm that products entering the U.S. meet regulatory expectations, prevent adulteration, and maintain supply chain integrity across all imported food categories.
This guide outlines key requirements for Supplier Identification & Risk Screening aligned with 21 CFR 1.500–1.514, global best practices, and industry-standard risk-based methodologies.
Supplier Identification & Risk Screening Checklist
✔ Supplier Identification & Qualification
- Collect complete supplier contact information and facility details
- Identify facility registration status (FEI, DUNS, FDA registration when applicable)
- Validate product categories, process steps, and facility capabilities
- Confirm compliance history and certification status (GFSI, ISO 22000, HACCP, etc.)
✔ Hazard-Based Risk Assessment
- Identify known or reasonably foreseeable biological, chemical, and physical hazards
- Evaluate ingredient risks, country-of-origin risks, and process risks
- Review historical data: recalls, import alerts, warning letters, Form 483s
- Assign risk levels using structured risk-rating criteria (low, medium, high)
✔ Supplier Food Safety Documentation Review
- Collect and assess food safety plans, HACCP/HARPC documentation, and preventive controls
- Review process validation and verification records
- Evaluate third-party audits, COAs, lab test results, and sanitation programs
- Verify allergen controls, traceability, and environmental monitoring programs (if applicable)
✔ Compliance & Regulatory Screening
- Check for FDA Import Alerts, admissibility issues, or detention without physical exam
- Review regulatory history from FDA, USDA, CFIA, or competent foreign authorities
- Assess compliance with U.S. standards and applicable commodity-specific regulations
✔ Risk-Based Determination of Supplier Verification Activities
- Match the supplier’s risk level with required verification measures
- Determine need for onsite audits, document reviews, sampling/testing, or annual reassessments
- Document the scientific and regulatory basis behind verification decisions
✔ Documentation, Approval & Continuous Monitoring
- Record all findings in the FSVP Supplier Approval File
- Maintain version-controlled screening records and annual updates
- Plan ongoing re-evaluations based on new hazards, changes in operations, or compliance events
- Ensure documentation meets FDA inspection-readiness standards
Support for FSVP Supplier Screening
FSVP Services provides specialized support to help importers build complete, compliant, and audit-ready FSVP programs:
- Customizable supplier screening & approval templates
- Risk-ranking tools aligned with FDA requirements
- Evaluation of foreign supplier food safety plans and certifications
- Import alert monitoring and compliance-history checks
- Scientific justification templates for verification decisions
- Fully managed FSVP services or hybrid support models
- On-site/virtual consultations for high-risk supplier review
Let our experts help you build an FSVP program that protects your brand and ensures regulatory compliance.
Ready to Screen Your Suppliers?
Get a structured, compliant, and defensible Supplier Approval System.
Request Supplier Screening like this…
- Book Your Free FSVP Consultation
- Request a Sample Supplier Screening Template Package
- Get a Custom Quote for Managed FSVP Services
This content is adapted from publicly available requirements and guidance related to the Foreign Supplier Verification Program (FSVP), including sections of 21 CFR Part 1 Subpart L, FDA compliance guidance, Codex Alimentarius risk analysis principles, and industry best practices used in global food safety programs.
For regulatory compliance, importers must follow the officially published requirements applicable to their region and product type, as issued by the FDA or other competent authorities. This material is intended for educational and informational purposes and does not substitute for review of official regulations.
FSVP Services is an independent service provider and is not affiliated with, endorsed by, or certified under any specific FSVP, FDA, Codex, or GFSI program owner.
References to FDA regulations, Codex principles, or GFSI frameworks are for informational purposes only and do not imply endorsement, approval, or partnership by any regulatory body, program owner, or certification authority.
Fees and Subscriptions
Optional Add-On Modules (Subscribe per user/month)
| Add-On Feature | Description | Price/User/Month |
|---|---|---|
| Supplier Approval Management | Manage organization’s legal records and entity information | $59 |
| Products Management | Organize product specifications, attributes, labeling, packaging, testing, and category risk | $59 |
| Customer Requirements Management | Maintain customer requirements documentation for traceability | $59 |
| Food Fraud Vulnerability Assessment (FFVA) | Document Food Fraud Vulnerability Assessments and mitigation plans | $69 |
| Corrective and Preventive Action (CAPA) Management | Track and resolve non-conformities, audit findings, and follow-up tasks | $49 |
| E-Forms (up to 10) | Digitized monitoring and verification forms | $99 |
| Custom Digital Form | One-time setup for custom form workflows | $300/form |
| Risk Assessment | Build and manage product- or category-specific hazard evaluations | $59 |
| Internal Audit Module | Schedule and track internal audits, findings, and improvements | $59 |
Custom Packages Available
- • Starts at $649 per month per facility, with core modules and certain add-ons included
- • Ideal for medium to large enterprises, corporations, and multi-facility organizations
Ideal For:
- • U.S. Importers under FSVP
- • Foreign Suppliers using U.S. Agents
- • Food Brands entering the U.S. market
- • Regulatory Consultants managing multiple importers
- • Warehouses or co-packers verifying international shipments
