FSVP Compliance Readiness – Gap Assessment Services

Assess and Strengthen Your FSVP Program Before FDA Inspection

Are you a U.S. importer or a foreign supplier working with a U.S. buyer under the FDA’s Foreign Supplier Verification Program (FSVP)?
Our FSVP Gap Assessment Service is designed to help you evaluate the completeness and compliance of your FSVP records and programs before a regulatory review or inspection.

We help you:
✓ Identify missing or inadequate verification records
✓ Ensure supplier compliance with 21 CFR Part 1 Subpart L

(Foreign Supplier Verification Programs for Food Importers)
✓ Gain peace of mind before FDA arrives

Who this service is for

This service is ideal for U.S.-based importers or their designated agents who need to verify that their current FSVP Program is compliant with FDA requirements. It is also useful for foreign suppliers who are expected to comply with FSVP through their U.S. buyers. The gap assessment is recommended after key documents (supplier approval, hazard analysis, verification activities) have been gathered or drafted.

Scope of Work

1. Pre-Assessment Planning and Consultation

• Define import scope, product categories, and importer obligations.
• Identify applicable exemptions or modified requirements.

2. Document and Record Review

Assess completeness of key records:

• Supplier Approval
• Foreign Supplier Hazard Analysis
• Written Assurance (if applicable)
• Verification Activities
• Corrective Actions
• Annual Reevaluation
• Recordkeeping Practices

3. FSVP Gap Assessment

• Develop SOP templates supporting each functional area required under 21 CFR 507:

∘ §1.500 – Purpose
∘ §1.501 – Applicability
∘ §1.502 – Scope of Covered Food
∘ §1.503 – Foreign Supplier Identification
∘ §1.504 – Hazard Analysis Requirements
∘ §1.505 – Supplier Evaluation and Approval
∘ §1.506 – Verification Activity Scheduling
∘ §1.507 – Verification Recordkeeping
∘ §1.508 – Corrective Action Protocols
∘ §1.509 – Reevaluation Timelines
∘ §1.510 – Record Maintenance
∘ §1.511 – Importer Identification
∘ §1.512–1.514 – Modified Requirements and Enforcement

• Check for consistency with product risk level, supplier performance, and frequency of import. • Review procedures for handling serious non-compliances and updating records.

4. Corrective Action Plan Development

• Organize findings by compliance section and risk level.
• Recommend specific documentation and procedural improvements (if applicable).

5. Corrective Action Plan Development

• Deliver a comprehensive report detailing observations, document gaps, and areas of risk.
• Provide recommendations to close compliance gaps.

Deliverables

• FSVP Compliance Gap Assessment Report
• Documented Compliance Checklist
• Customized Corrective Action Plan (CAP) with recommendations (if applicable)

Service Fee (Per FSVP Program):

Service Mode	Timeline	Total Fee (USD)	Action
Remote FSVP Gap Assessment	5–7 business days	$4,750.00	Purchase
On-Site FSVP Gap Assessment	4–6 business days	$4,900.00 + miscellaneous	Purchase

Notes:

• Miscellaneous costs (travel, lodging, etc.) apply to on-site engagements, and are excluded from the service quote.

Optional Add-Ons

• Corrective Actions - starts at $75.00 per document
• FSVP Program SOP Toolkit for Importers – $1,550.00
• FSVP Agent Services – starts at $199/year
• InterlinkIQ FSVP Management System – starts at $99/mo per user