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FSVP Compliance Support for Very Small Importers

Align with 21 CFR 1.500–1.514 as a Qualified Exemption

Under the FDA’s Foreign Supplier Verification Program (FSVP) requirements (21 CFR 1.500–1.514), U.S. importers of food for humans and animals must verify that their foreign suppliers meet applicable U.S. safety standards.

A Very Small Importer (VSI), as defined by the FDA, is an importer with less than USD 1 million in average annual sales of human and animal food combined (or less than USD 2.5 million for animal food) during the previous three years. While VSIs are eligible for modified FSVP requirements, they must still maintain records demonstrating eligibility and ensure their suppliers produce food under conditions meeting U.S. safety standards.

Our service supports VSIs in setting up the essential FSVP documentation system, maintaining eligibility evidence, and fulfilling regulatory expectations while keeping the process simple and practical.

Ideal For

  • • U.S. importers qualifying as Very Small Importers (VSI) under 21 CFR 1.512.
  • • Businesses importing finished or packaged foods such as canned, bottled, or jarred goods.
  • • Small-scale importers seeking FDA-ready documentation without the complexity of full-scale FSVP implementation.

Scope of Work

Our team provides flexible support in establishing and maintaining your VSI FSVP compliance records.

Documentation Tool Templates

• Development and provision of ready-to-use templates necessary for VSI FSVP documentation, which may include but are not limited to:
  • ∘ VSI Qualification Record
  • ∘ Importer Information Sheet
  • ∘ Product and Supplier Listing Form
  • ∘ Supplier Approval Summary Sheet
  • ∘ FSVP Recordkeeping Log
  • ∘ VSI Attestation Form

Documentation System Set-Up

  • • Assessment of company information in relation to qualifying exemptions
  • • Customization and organization of VSI FSVP documentation system, including review of importer information and supplier details, and integration of client-specific data into templates with provision of document control list and file naming guidelines.

Implementation Support:

  • • Ongoing support to ensure effective use and maintenance of the VSI FSVP documentation system
  • • Records management of qualifications for exemption.
  • • Remote orientation for recordkeeping procedures.
  • • Review of VSI qualification data and confirm attestation accuracy.
  • • Provision of recommendations for ongoing supplier document updates.
  • • Final review of all documentation for FDA readiness.

Deliverables

  • • Confirmation of customs broker engagement and contact details.
  • • Record of communications and shipment clearance status.
  • • Organized compliance documentation for coordination with the broker.

Pricing Packages

Service Description / Pricing Action
Documentation Tool Templates Starts at $12 per document Contact Us
Documentation System Set-Up Custom Quote Get a Quote
Implementation Support Starts at $19 per hour Get a Quote
Estimated Completion is based on the number of foreign suppliers.

Add-Ons

  • • FSVP Maintenance Support –Starts at $19 per hour (record updates, document renewal reminders, and audit readiness checks).
  • • FSVPQI Representation – The Company may act as your Qualified Individual for FSVP oversight (quotation upon request).
  • • Supplier Audit Preparation – Assistance in preparing supplier documents for GFSI or FDA verification purposes.

Start Your U.S. Import Journey with Confidence.

Let’s simplify compliance, and make your VSI FSVP setup effortless, accurate, and FDA-ready.

Disclaimer

Scope of work indicated covers solely representation only and is subject to Terms of Service.

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