Choosing the Right FSVP Verification Tools
Under FDA’s Foreign Supplier Verification Program (FSVP), importers must verify that the food they bring into the U.S. has been produced safely and in compliance with U.S. standards. At the heart of this requirement are verification activities, the processes importers use to assess whether their foreign suppliers are effectively controlling hazards.
Below is a clear breakdown of the primary verification tools, how to determine which one is appropriate for a given hazard or supplier, and best practices for documenting your verification work.
Key Verification Tools Under FSVP
Importers may rely on different verification methods depending on the level of risk. The most common options include:
1. On-Site Audits
An auditor evaluates the supplier’s facility, controls, records, and implementation of food safety plans.
Use this when:
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The hazard could cause serious adverse health consequences or death (SAHCODHA).
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Use this especially when the supplier is new, has weak compliance history, or operates in a region with higher food safety risks.
On-site audits may be conducted by qualified third party auditors. The audit must be in English.
2. Sampling & Testing
Testing incoming product (e.g., micro testing, pesticide residues, heavy metals) helps verify that hazards are being controlled at the supplier’s facility.
Use this when:
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The hazard is reasonably likely to occur but not SAHCODHA-level.
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Historical test data or past compliance issues suggest periodic verification is beneficial.
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The product is high-risk but easily testable (e.g., spices, produce, seafood, additives).
3. Review of Supplier Monitoring Records
This includes reviewing:
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CCP monitoring logs
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Preventive control records
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Corrective action logs
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Batch records
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Environmental monitoring results
Use this when:
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The supplier has strong food safety programs and a consistent compliance history.
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The hazard is well-controlled with documented preventive controls.
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You need ongoing verification but not at the intensity of audits/testing.
Record reviews can also supplement audits for continuous oversight.
It should be noted that the foreign supplier does not need to perform these activities by themselves. Per FDA guidelines:
An importer can rely on another entity (other than the foreign supplier) to determine and perform appropriate supplier verification activities, so long as the importer reviews and assesses the relevant documentation.
The importer/FSVP agent needs to assess the relevant documentation and must document that a review has taken place (we will review documentation later).
How to Select the Right Verification Activity?
Choosing the correct verification method isn’t one-size-fits-all. FDA expects importers to consider:
1. The Nature and Severity of the Hazard
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SAHCODHA hazards → on-site audit recommended annually.
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Moderate hazards → testing or record review may suffice.
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Low hazards → periodic document review may be appropriate.
2. Supplier Performance
Consider the supplier’s:
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History of FDA compliance issues, import alerts, recalls
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Food safety certifications
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Transparency and responsiveness
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Corrective action history
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Manufacturing process maturity and controls
A strong, reliable supplier may require less intensive verification compared to a new or higher-risk supplier.
3. Characteristics of the Food
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Perishable? High-risk categories may require audits or testing.
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Shelf-stable? Often lower risk.
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Complex processing? May need deeper verification.
4. Geographic/Regional Factors
Regions with known safety or regulatory challenges may require more robust verification like audits or testing.
Best Practices for Documenting Verification, Corrective Actions & Follow-Up
Proper documentation is essential, not only for compliance but to demonstrate that you are making informed, risk-based decisions.
1. Document Each Verification Activity Clearly
Include:
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What activity was performed
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Who performed it (must be a qualified individual)
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Date, scope, and findings
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How the activity supports control of identified hazards
2. Keep Detailed Corrective Action Records
If a hazard is not adequately controlled or verification uncovers a deficiency, document:
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The issue discovered
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The supplier’s corrective action
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Your follow-up to ensure the issue was resolved
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Any interim steps taken (e.g., increased testing, temporary suspension)
3. Maintain a Verification Schedule
FDA expects a written plan outlining how often each activity is performed based on risk.
4. Review and Update Regularly
Re-evaluate your verification approach whenever:
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New hazards emerge
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The supplier changes processes
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A food safety incident occurs
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FDA issues new regulations or guidance
Conclusion
Verification under FSVP is about choosing the right tools to ensure your foreign suppliers are producing safe food. Whether you rely on on-site audits, sampling and testing, or monitoring record reviews, the key is to match the verification intensity to the hazard and supplier risk level then document your process thoroughly.
Here at Ken Lehat & Associates (KLA), we guide importers through this process. We can also serve as you FSVP agent, bearing the responsibility for FDA food safety standards. For more information about verification activities and FSVP, please contact us:
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