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Foreign Supplier Verification Program (FSVP) – Toolkit

Documentation Toolkit Based on 21 CFR 1.500–1.514 – Foreign Supplier Verification Programs for Food Importers

To support efficient and scalable FSVP implementation, this package provides importers and food businesses with a full set of editable, ready-to-use documentation templates. Aligned with the requirements of 21 CFR 1 Subpart L, these materials help streamline supplier verification and meet FDA expectations without the need for a full-service compliance engagement.

Scope of Work

FSVP Program Templates

Provide a complete suite of FSVP-compliant standard operating procedures (SOPs) and supporting forms:
  • • Includes editable SOPs, policies, registers, forms, and job aids
  • • Designed to support hazard analysis, supplier evaluation, recordkeeping, and corrective action processes

Supplier Verification SOPs

Offer templates for evaluating foreign suppliers, including risk-based protocols, documentation requirements, and certification criteria:
  • • Supports compliance with 21 CFR 1.505 and 1.506

Corrective Action SOPs

Templates for identifying, documenting, and responding to supplier non-conformance and food safety risks:
  • • Includes CAPA forms and escalation workflows

Periodic Review and Evaluation SOPs

Standardized documents for conducting annual supplier reviews and verifying the continued accuracy of FSVP documentation:
  • • Aligns with 21 CFR 1.508 requirements

Recordkeeping and Document Control SOPs

Provide procedures for organizing, storing, and retaining documentation in compliance with 21 CFR 1.512:
  • • Includes version control guidance and document retention timelines

Compliance Monitoring SOPs

Templates for tracking ongoing supplier performance, monitoring FDA alerts, and updating internal compliance status.

Deliverables

FSVP Compliance Package

Templated FSVP documentation binder including editable SOPs, registers, and forms tailored to regulatory requirements.

Customized SOPs & Compliance Documents

SOPs tailored to comply with 21 CFR 1 Subpart L - Foreign Supplier Verification Programs for Food Importers
  • § 1.500 What Foreign Supplier Verification Programs Apply To and Who Must Comply
  • § 1.501 Applicable Definitions
  • § 1.502 General Requirements of a Foreign Supplier Verification Program
  • § 1.503 Who Must Develop and Perform a Foreign Supplier Verification Program
  • § 1.504 Use of Qualified Individuals in Foreign Supplier Verification Programs
  • § 1.505 Hazard Analysis for Identifying Risks Associated with Imported Food
  • § 1.506 Evaluation of Food and Foreign Suppliers
  • § 1.507 Approval and Use of Foreign Suppliers
  • § 1.508 Requirements for Conducting Foreign Supplier Verification Activities
  • § 1.509 Reevaluation of Food and Foreign Suppliers
  • § 1.510 Corrective Actions for Identified Problems with Foreign Suppliers
  • § 1.511 Records That Must Be Maintained for Foreign Supplier Verification Programs
  • § 1.512 Compliance Status of Imported Food
  • § 1.513 Modified Requirements for Very Small Importers and Certain Food Types
  • § 1.514 Modified Requirements for Foods Subject to Preventive Controls or Produce Safety Rules
  • § 1.515 Applicable Exemptions

Supplier Verification SOPs

Step-by-step SOPs for evaluating supplier risk and reviewing documentation.

Recordkeeping SOPs

Guidance for managing compliance records and maintaining an audit-ready filing system.

Corrective Action SOPs

Procedures for addressing supplier issues, food safety risks, or compliance failures.

Review and Monitoring SOPs

Templates for conducting periodic reviews and updating documentation based on supplier performance or regulatory changes.

Fees and Subscriptions

Package Description Fee
FSVP Template Toolkit Editable SOPs, checklists, policies, and forms $1,550.00 USD Purchase

Ideal For:

Importers, brand owners, and food businesses looking to establish a self-managed FSVP system with FDA-compliant documentation, especially those preparing for audit readiness, expanding supplier networks, or seeking a cost-effective compliance solution.

Get Started: Contact us at info@consultareinc.com or submit your request via our online form.