FSVP Compliance in Audits: FSVP and Quality Audits - Why They Matter

The Foreign Supplier Verification Program (FSVP) is one of the most significant food safety requirements introduced by FSMA. It shifts responsibility for verifying foreign food supplier compliance from the FDA to US importers — creating a direct commercial imperative for foreign food manufacturers to demonstrate compliance with US food safety standards. This guide covers FSVP requirements and their implications for foreign food manufacturers in 2026.

What Is FSVP?

FSVP requires US importers of food to verify that the food they import has been produced in a manner providing the same level of public health protection as applicable FDA food safety regulations. Importers must evaluate food safety risks, conduct verification activities, and maintain documentation demonstrating verification was performed.

What FSVP Requires of US Importers

Hazard Analysis

The FSVP importer must conduct a hazard analysis identifying known or reasonably foreseeable biological, chemical, and physical hazards. This analysis must consider the nature of the food, intended use, and severity of consequences if hazards are not controlled.

Supplier Verification Activities

• Onsite audits of the foreign supplier's facility — typically required for suppliers with significant food safety risks

• Sampling and testing of food lots — appropriate for verifying specific chemical or microbiological hazards

• Review of the supplier's food safety records — HACCP plans, sanitation records, and testing results

• Review of the supplier's FDA compliance history

Documentation and Recordkeeping

FSVP requires extensive records: hazard analysis, supplier evaluations, verification activity records, and corrective action documentation. Records must be maintained for at least two years and be available for FDA inspection.

Implications for Foreign Food Manufacturers

FSVP fundamentally changes the commercial relationship between foreign food manufacturers and US importer customers. Importers managing their FSVP obligations cannot source from foreign suppliers who refuse verification activities or cannot provide food safety documentation.

Foreign manufacturers should maintain current FDA food facility registration, develop a current food safety plan (HACCP or preventive controls-based), be prepared to host importer-conducted or third-party audits, and respond promptly to any FDA inquiries or inspections.

Quality Audits as FSVP Verification Activities

Third-party quality audits are among the most widely used FSVP verification activities. GFSI-recognized audit standards — BRC, SQF, FSSC 22000, and IFS — are broadly accepted as appropriate benchmarks. A foreign manufacturer with a current GFSI certification can provide it to US importer customers as evidence of verification.

FSVP and FDA Inspections

The FDA has an active FSVP inspection program. Importers with inadequate FSVP programs receive warning letters or face import holds. Because FSVP compliance directly references foreign supplier performance, importer inspections can trigger scrutiny of foreign manufacturing facilities.

How Axentra Supports FSVP Compliance

Axentra assists foreign food manufacturers with FDA facility registration, food safety documentation review, preparation for FSVP supplier audits, and Prior Notice filing for import shipments. Contact us for a free assessment of your FSVP readiness.