Building or updating a Foreign Supplier Verification Program (FSVP) is not guesswork. The FDA’s expectations are precise, document-driven, and increasingly enforced. Whether you’re preparing for your first inspection or strengthening an existing program, a clear, structured checklist is one of the most valuable tools an importer can rely on.

This guide distills the core components of a compliant FSVP into a step-by-step reference you can use immediately. It also reinforces where FDA’s investigative focus truly sits—in the alignment between your records, your supplier’s controls, and the hazards associated with each product.

Start With the Right Foundation: Identify the Correct FSVP Importer

Before any verification activity matters, the FDA must be able to determine that the correct party is listed as the FSVP Importer. Incorrect identification leads directly to records gaps and enforcement. If you need a refresher, revisit FSVP Importer responsibilities.

A current list of foods imported – with product name and FDA food category (if applicable) –should be documented.  Additionally, a list of foreign suppliers – name, address and the foods supplied by each supplier must be maintained.

Once the responsible party, foods and suppliers are established, the rest of the program can be built with precision.

Step 1: Gather and Maintain Required FSVP Records

Every FSVP begins with documentation. FDA inspections focus on whether the importer has maintained the records that demonstrate oversight. At minimum, be sure you have:

• A written FSVP documenting your program
• Product-specific hazard analyses
• Supplier evaluations and approval decisions
• Verification activity results and follow-up actions
• Corrective action records
• Written procedures for reanalysis
• Records of qualified individual involvement

FDA investigators look for consistency: the records should align with the hazards reasonably foreseeable in the food and the preventive controls your supplier has in place. If these are missing or incomplete, inspectors will document the gap. Note that FDA requires that FSVP records be written (paper or electronic), be in English, be retained for at least 2 years after creation AND be available within 24 hours of fdA request.

Step 2: Conduct or Obtain a Hazard Analysis

Each product requires its own hazard analysis conducted or reviewed by a qualified individual. A foreign supplier may provide one, but the FSVP Importer is responsible for evaluating it. Ensure it includes:

• Biological, chemical, radiological and physical hazards along with economically motivated adulteration
• Evaluation of hazard severity and probability
• Identification of who controls each hazard (supplier, importer, or another entity)

If your internal team or your PCQI conducts the hazard analysis, make sure documentation reflects their evaluation steps. Importers who need clarity on documenting qualified individual activities often refer to PCQI documentation guidance.

Step 3: Evaluate and Approve Your Foreign Supplier

FDA expects importers to base supplier approval on risk, not convenience. Your evaluation must consider:

• The supplier’s safety performance and history (ie. audit results, sampling and testing data)
• Their hazard controls and preventive systems
• Corrective actions for past issues
• Compliance with other regulatory standards

Approval should be documented with a clear rationale. When suppliers change processes or locations, re-evaluation is required.

Step 4: Determine Appropriate Verification Activities

Verification activities must match the specific risks posed by the product and supplier. Common verification activities include:

• Reviewing supplier food safety records
• On-site audits conducted by a qualified auditor
• Sampling and testing
• Documented corrective actions

Your records must show not only what was performed, but why that activity was appropriate given the hazard analysis.

If an FDA inspection identifies that verification activities don’t match identified hazards, you may need to correct your program quickly.

Step 5: Maintain Ongoing Monitoring and Reassessment

FSVP is not a static program. Importers must:

• Reassess suppliers at least every three years
• Reevaluate sooner if new hazards, recall, supplier changes, etc. emerge
• Document follow-up to any supply chain issues

FDA’s expectation is continuous verification—a living program that shifts as suppliers, products, or risks evolve.

Step 6: Align Your Program With Upstream Safety Controls

Most importers already rely on upstream systems like HACCP or HARPC. Aligning FSVP records with those frameworks strengthens credibility and reduces duplication. If you need structure for reviewing or modernizing supplier controls, see building an effective HACCP Plan.

A Downloadable Checklist Template for Importers

A working checklist becomes more effective when shared across procurement, QA, and regulatory teams. Your internal version should reflect:

• Every verification decision required
• Every record your team must generate or maintain
• The frequency and responsibility for each activity
• A method for tracking supplier status and reanalysis dates

When used consistently, this becomes the backbone of both daily compliance and long-term audit readiness.

Why This Checklist Matters: FDA Inspections Are Record-Centric

FSVP inspections remain one of the most documentation-heavy activities FDA conducts. The agency is not simply verifying that hazards exist—it is verifying that you recognized them and validated your supplier’s ability to control them. Most violations arise not from missing controls, but from missing or incomplete records.

The more complete your FSVP checklist, the more confidently your team can meet FDA’s expectations.

Your Next Step: Ensure the Team Responsible for FSVP Is Properly Trained

A checklist is only as strong as the people implementing it. If your personnel are unsure how to evaluate hazards, determine supplier risks, or document verification activities, formal training creates immediate clarity and ultimately drives FSVP compliance.

Registrar Corp’s FSVP Training provides:

• A full walk-through of every FSVP requirement
• Guidance on building and maintaining compliant records
• Practical examples of verification activities that meet FDA expectations
• Tools that help importers implement a checklist like the one above with confidence

If you want certainty, consistency, and compliance across your entire program, explore Registrar Corp’s FSVP Training today.