When the FDA conducts an FSVP inspection, nearly every conclusion they reach comes down to one thing: your records. Not your intent, not your supplier’s assurances, not the strength of their HACCP plan alone—your documentation. Importers who understand what complete, compliant records look like stand in a far stronger position during FDA review.

This article illustrates the types of example records FDA expects to see, provides sample structures you can model, and links you to the procedures and corrective-action strategies that support a fully compliant program.

Why FSVP Records Matter More Than Policies or Intent

FSVP is one of the most documentation-driven regulations under FSMA. FDA’s questions are aimed at verifying your FSVP compliance, traceability, and your ability to control food safety risks before products enter U.S. commerce.  FDA investigators rarely ask theoretical questions. Instead, they ask:

• Where is your hazard analysis evaluation for each food/supplier?
• How did you evaluate known or reasonably foreseeable hazards?
• How did you approve this supplier—and where is the rationale?
• How did you determine verification activities were appropriate?
• What are examples of corrective actions with a supplier/product noncompliance?
• Where is the record of reassessment?
• Who reviewed and signed these documented decisions?

If the records are incomplete, missing, generic, or misaligned, the FDA considers the FSVP inadequate—regardless of how well your supplier performs.

Importers seeking procedural clarity often review FSVP procedure examples before building or revising their documentation system.

Example 1: Hazard Analysis Evaluation Record

FDA expects the importer to evaluate the supplier’s hazard analysis for each product—not merely attach or store it.

A compliant record includes:

• Identification of foreseeable hazards
• Assessment of severity and likelihood
• Statement of who controls each hazard (supplier, importer, or another entity)
• Notes on the importer’s evaluation of the supplier’s controls
• Signature, name, and title of the qualified individual completing the review
• Date of evaluation

Why importers fail: Many rely on a supplier’s HACCP plan without documenting their own evaluation. FDA considers this a missing record.

Example Template: Hazard Analysis Evaluation

Product: ___

Supplier: ___

Hazards Identified: (List biological, chemical, radiological and physical hazards)

Supplier Controls Identified: ___

Importer Evaluation: (Assessment of adequacy, gaps, or needed verification activities)

Conclusion: Hazard controls are / are not adequate.

Qualified Individual: Name, Title

Signature & Date: ___

Example 2: Supplier Approval Decision Record

Supplier approval is risk-based. FDA must see the rationale behind your decision.

A compliant approval record shows:

• Supplier performance history
• Review of complaints, recalls, warning letters or outbreaks
• Assessment of regulatory compliance
• Review of safety documentation (HACCP, audits, certifications)
• Evidence-based final approval status (approved, conditionally approved, or rejected)
• Justification for the approval decision
• Date and reviewer signature

Common failure: A supplier marked “approved” with no written justification. FDA interprets this as no approval at all.  FDA expects a clear supplier disqualification procedure.

Example Template: Supplier Approval Record

Supplier: ___

Reviewed Documents: (Audits, HACCP, certifications, product testing, record review, compliance history)

Risk Level Assigned: Low / Medium / High

Approval Status: ___

Justification: (Why the supplier is approved or conditionally approved)

Reviewer: Name, Title

Signature & Date: ___

Example 3: Verification Activity Records

Verification activities must logically match the hazards identified.

A complete verification record includes:

• Description of the verification activity (audit, testing, document review)
• Who performs the verification activities and their qualifications.
• Frequency of the activity
• Results and conclusions
• Follow-up or corrective actions
• Updated risk rating if applicable

Why importers fail: Selecting verification activities for convenience rather than risk—and recording only the activity, not the reasoning.

Example Template: Verification Activity Record

Product: ___

Supplier: ___

Verification Activity Type: ___

Frequency: ___

Findings: ___

Corrective Actions (if any): ___

Revised Risk Level: ___

Reviewer Signature & Date: ___

Example 4: Re-Evaluation / Reassessment Records

FSVP requires reassessment at least every three years—or sooner if new hazards appear.

A compliant reassessment record includes:

• Review of updated supplier performance
• Updated hazard analysis
• Updated verification activity plan
• Verification of qualified personnel
• Decision to maintain or adjust approval status
• Documented reasoning
• Signature and date

Common failure: Relying on the original approval indefinitely. FDA considers this a breakdown in importer oversight.

Example Template: Reassessment Record

Product:  ____

Supplier: ___

Reassessment Trigger: Routine (3-year) / Event-driven

Updated Findings: ___

Revised Verification Activities: ___

Approval Status: Maintained / Modified / Revoked

Reviewer: Name, Title

Signature & Date: ___

Example 5: Corrective Action Documentation

When hazards aren’t adequately controlled or verification activities uncover deficiencies, corrective actions must be documented.

Complete corrective action records include:

• Description of the issue
• Immediate containment measures
• Long-term and effective corrective plan
• Supplier response
• Reassessment of supplier status
• Adjustments to verification frequency

Bringing It All Together: An FDA-Ready FSVP Record System

A strong record program connects all elements:

• Hazard analysis → supplier approval
• Supplier approval → verification activities
• Verification activities → reassessment and corrective actions

When the FDA reviews your documentation, they want to see:

• Clear logic
• Complete records
• Consistent implementation
• Evidence that a qualified individual reviewed decisions

Importers looking to align their supply-chain documentation with preventive controls often revisit HACCP’s evolving role.

Your Next Step: Build Records That Withstand FDA Inspection

Records are the backbone of FSVP compliance, and your team’s ability to produce complete, consistent, and well-reasoned documentation depends on their training.  Having a trained team is critical – not optional- for FSVP compliance and FDA investigators treat it as a core indicator of importer control and accountability, not an administrative detail.

Registrar Corp’s FSVP Training helps importers:

• Understand exactly what records FDA expects
• Build documentation systems aligned with regulatory logic
• Strengthen supplier evaluation and verification decisions
• Prepare confidently for FDA inspection

If you want FSVP records that satisfy FDA—not just in theory, but in practice—explore Registrar Corp’s FSVP Training today.