Over the past five months (August–December 2025), FDA has cited importers for multiple Foreign Supplier Verification Program (FSVP) violations. In this post, we highlight the most common violations and share real-world, anonymized examples that show where importers went wrong.
The Most Common FSVP Violations
1. No Written FSVP in Place
What FDA sees:
Importers bringing food into the U.S. without a documented FSVP for the products they import.
Why it happens:
- Importers assume the foreign supplier or broker is responsible
- Importers are unaware that FSVP applies to them
- Importers believe GFSI certification replaces FSVP requirements
Why it’s a problem:
FDA requires a product- and supplier-specific FSVP. When no plan exists, FDA issues an automatic violation.
2. Inadequate Hazard Analysis
What FDA sees:
- Generic hazard analyses copied from templates. Hazards marked “not applicable” without justification
- Failure to consider biological, chemical, and physical hazards
Why it happens:
- Over-reliance on supplier assurances
- Limited Preventive Controls knowledge
- Failure to tailor the analysis to the specific food and process
Key FDA concern:
Hazard analyses must be product-specific and defensible, not boilerplate.
3. Failure to Appropriately Verify Foreign Suppliers
What FDA sees:
- No supplier verification activities
- Verification activities that do not match the level of risk
- Reliance on outdated or incomplete audits
Common verification gaps:
- No onsite audit for high-risk foods
- Certificates of Analysis (COAs) accepted without validation
- Audits conducted by unqualified parties
FDA expectation:
Importers must consistently apply risk-based ana appropriately frequent supplier verification.
4. Missing or Incomplete Records
What FDA sees:
- Records not produced within 24 hours
- Missing verification documentation
- Undated or unsigned records
Why this matters:
From FDA’s perspective, if it isn’t documented, it did not happen.
5. No Qualified Individual Overseeing FSVP
What FDA sees:
- No evidence that a qualified individual developed or reviewed the FSVP
- Importers unable to explain their program during inspection
Common misconception:
Having a consultant write the plan for you is not enough. FDA expects ongoing oversight and understanding.
Real-World Examples (Anonymized)
Example 1: No FSVP and No Documentation
What went wrong:
During an inspection, FDA requested the importer’s FSVP, but none existed. The importer stated that the Food Safety and Compliance Team would review the findings, develop product-specific FSVPs, and update FSVP training. Despite these verbal commitments, FDA issued a warning letter shortly afterward because no documented corrective actions were provided.
Corrective action requirement:
FDA required a response within 15 working days, including documentation demonstrating that corrective actions had been implemented.
Lessons:
- Importers are responsible for developing and maintaining an FSVP
- The FSVP must be in place before importation
- Corrective actions must be documented and submitted promptly
Example 2: Salmonella Outbreak and Multiple FSVP Failures
What went wrong:
During an FSVP audit, FDA found that the importer:
- Failed to follow written procedures to ensure food was imported only from approved suppliers
- Did not conduct a written hazard analysis for each food prior to import
- Lacked a documented foreign supplier approval process
- Failed to document supplier verification activities and their frequency
How it was discovered:
FDA initiated an inspection following a multistate Salmonella outbreak linked to products from the importer’s foreign supplier. All products from that supplier were placed on Import Alert, triggering a full FSVP audit.
Lessons:
- Supplier approval must be consistent and documented
- Hazard analyses must be customized for each food
- Verification activities must be relevant and risk-based
Example 3: Recall Without Documented Corrective Actions
What went wrong:
The importer recalled a product after a positive Salmonella test but failed to document any corrective actions. The importer did not suspend the foreign supplier without identifying the root cause of the adulteration and correcting it. Although the importer told FDA they would update the FSVP with internal communications and investigation records, FDA issued a citation due to a lack of supporting documentation.
FDA also noted that no hazard analysis had been conducted and that no recent third-party or onsite audit supported supplier approval.
How FDA found out:
Not specified.
Lessons:
- If corrective actions are not documented, FDA considers them not to have occurred
- Importers must discontinue use of suppliers until corrective actions are implemented and verified
Final Thoughts
Most FSVP violations are not the result of bad intent. They stem from misunderstandings, assumptions, or outdated practices. FDA inspections are becoming more detailed, and enforcement continues to increase.
A strong FSVP does more than satisfy FDA; it protects your supply chain, your customers, and your business.
If you are unsure where your program stands, a free consultation with Ken Lehat today can help prevent costly findings tomorrow.
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