The Foreign Supplier Verification Program (FSVP) is a critical rule under the FDA’s Food Safety Modernization Act (FSMA) requiring U.S. importers to verify that all imported food meets U.S. safety standards.
This rule has been in effect since 2017 for large businesses and 2018 for small businesses, shaping how companies manage global supply chains and regulatory documentation.
ReposiTrak simplifies compliance by automating FSVP record management, supplier verification, and document tracking — ensuring readiness for FDA inspection at any time.
Who Is the Importer Under FSVP?
Under the FDA’s definition, the importer is typically the U.S. owner or consignee of the food at the time of entry. If no such party exists, the importer may be the U.S. agent or representative of the foreign owner or consignee.
In practice, several supply chain partners may be positioned to fulfill importer obligations. Determining this responsibility requires coordination between retailers, distributors, and foreign suppliers.
Determining the Responsible Party
Clear communication among trading partners is essential to assign importer roles accurately. Considerations include:
- Which party ensures that the foreign supplier meets U.S. food safety standards
- Who has knowledge of supplier operations and controls
- Who manages financial and physical ownership of the goods
- Who conducts supplier verification activities and corrective actions
FSVP Importer Responsibilities
Importers must evaluate known or reasonably foreseeable food safety hazards, assess foreign supplier performance, and verify that imported food is produced in compliance with U.S. standards.
Key actions include:
- Conducting hazard analyses
- Approving and monitoring suppliers
- Performing verification activities (e.g., audits, sampling, record review)
- Taking corrective actions when risks or deficiencies are identified
Required Records and Documentation
FSVP compliance requires maintaining detailed, accessible records for each imported product — available to the FDA within 24 hours of request and retained for at least two years.
Recommended documentation includes:
- Hazard analysis and control plans
- List of approved foreign suppliers
- Supplier evaluations and approval records
- Verification activities and frequency
- Corrective action documentation
- Periodic re-evaluation (at least every three years)
Managing Compliance Through Automation
Manual recordkeeping is time-consuming and error-prone, especially for importers managing numerous suppliers.
ReposiTrak’s compliance platform automates:
- Record creation and storage
- Supplier document verification
- Audit readiness and FDA response workflows
- Traceability integration with FSMA 204 requirements
By connecting supplier data and traceability information in one platform, ReposiTrak ensures full visibility and control over compliance operations.
FAQs
What is FSVP compliance?
FSVP compliance means verifying that imported food meets FDA standards for safety, hazard control, and supplier performance under FSMA.
Who is responsible for FSVP documentation?
Typically, the U.S. importer of record is responsible. However, this may be delegated to a U.S. agent representing the foreign supplier.
How does ReposiTrak support FSVP compliance?
ReposiTrak automates supplier document management, verification workflows, and audit readiness through its cloud-based compliance system.
