FSVP Compliance Guide for Food Importers

What Is the Foreign Supplier Verification Program (FSVP)?

The Foreign Supplier Verification Program (FSVP), codified at 21 CFR Part 1, Subpart L, requires US importers to verify that food imported into the United States meets US safety standards. FSVP importers must conduct hazard analysis, evaluate foreign suppliers, perform verification activities (such as audits, sampling, or record review), take corrective actions, and maintain records for at least two years. Non-compliance can result in import refusal and significant penalties. For the official FDA rule, see the FSMA Final Rule for Foreign Supplier Verification Programs.

The FSVP regulation became effective in May 2017 for most importers. Its primary goal is to ensure that imported food is produced in a manner that provides the same level of public health protection as food produced domestically under FDA's Preventive Controls or Produce Safety rules.

FSVP Core Objectives

Who Is the FSVP Importer?

Under FSVP regulations, the "importer" is defined as the US owner or consignee of the food at the time of entry into the United States. If there is no US owner or consignee at the time of entry, the importer is the US agent or representative of the foreign owner or consignee.

Understanding who qualifies as the FSVP importer is critical because this party bears all legal responsibility for compliance with FSVP requirements. The FSVP importer may be:

• The US buyer/owner: A company that purchases food from a foreign supplier and takes ownership before or at the time of import
• The consignee: The party to whom the food is being shipped if there is no US owner
• A customs broker: Only if acting as an agent of the foreign owner with FSVP responsibilities explicitly assigned

FSVP Importer Responsibilities

• Conduct hazard analysis for each food imported from each foreign supplier
• Evaluate foreign suppliers to ensure they meet US food safety standards
• Determine and conduct appropriate verification activities
• Take corrective actions when problems are identified
• Maintain comprehensive records of all FSVP activities
• Re-evaluate suppliers and verification activities at least every three years

What Are the Core FSVP Requirements?

FSVP compliance involves several interconnected requirements that work together to ensure imported food is safe. Here is an overview of the main components:

1. Hazard Analysis

Before importing food, you must conduct a hazard analysis to identify known or reasonably foreseeable hazards for each food you import. This analysis considers biological, chemical, and physical hazards that could be present due to:

• Natural occurrence
• Unintentional introduction
• Intentional introduction for economic gain

2. Supplier Evaluation

You must evaluate foreign suppliers to determine whether they meet applicable FDA safety standards. This evaluation considers:

• The supplier's food safety procedures and practices
• History of FDA warnings, import alerts, or other actions
• The supplier's compliance status
• Any other relevant factors

3. Verification Activities

Based on your hazard analysis and supplier evaluation, you must determine and conduct appropriate verification activities, which may include:

• On-site audits of the foreign supplier
• Sampling and testing of food
• Review of the supplier's food safety records
• Other appropriate verification activities

4. Corrective Actions

When verification activities identify that a foreign supplier is not producing food in compliance with US standards, you must take prompt corrective actions, which may include:

• Discontinuing use of the supplier
• Requiring the supplier to implement corrective actions
• Increasing verification activities

5. Record-Keeping

You must maintain records documenting all FSVP activities, including hazard analysis, supplier evaluations, verification activities, and corrective actions. Records must be maintained for at least two years.

How Do I Conduct an FSVP Hazard Analysis?

The hazard analysis is the foundation of your FSVP program. A thorough hazard analysis helps you identify potential risks and determine appropriate verification activities for each food-supplier combination.

Step 1: Identify Potential Hazards

Review each food product you import and identify all known or reasonably foreseeable hazards:

Step 2: Evaluate Hazard Significance

For each identified hazard, evaluate whether it is a hazard requiring a control. Consider:

• Severity: The potential consequences if the hazard occurs
• Probability: The likelihood of the hazard occurring

Step 3: Determine Control Measures

For hazards requiring control, identify what controls are needed and where they should be applied in the supply chain. Controls may include:

• Controls at the foreign supplier (preventive controls, cGMP)
• Controls applied by you or a subsequent entity
• Controls inherent to the food (pH, water activity, etc.)

Step 4: Document Your Analysis

Your hazard analysis must be documented and include your conclusions about each hazard identified. This documentation supports your decisions about supplier verification activities.

What Verification Activities Does FSVP Require?

Verification activities are the actions you take to verify that your foreign suppliers are controlling identified hazards. FSVP provides flexibility in choosing verification activities appropriate to the risk profile of the food and supplier.

Types of Verification Activities

On-Site Audits

Audits are required for foods with hazards requiring a control. Audits must be conducted by a qualified individual and may be performed by your own staff, third-party auditors, or the supplier's government agency.

• Initial audit before first import recommended
• Periodic audits based on risk (annually for high-risk)
• Unannounced audits may be appropriate for high-risk suppliers

Sampling and Testing

Testing can verify that suppliers are controlling specific hazards. Appropriate uses include:

• Testing for pathogens in ready-to-eat foods
• Testing for allergens
• Testing for pesticide residues
• Testing for heavy metals

Review of Food Safety Records

Reviewing supplier records can provide evidence of ongoing compliance. Records to review may include:

• HACCP plans and records
• Sanitation records
• Testing results
• Corrective action records

Other Verification Activities

Other activities may be appropriate depending on circumstances:

• Lot-by-lot certification
• Annual certifications
• Periodic testing of incoming shipments
• Review of supplier qualifications and certifications

How Often Must I Re-Evaluate Foreign Suppliers?

Initial Supplier Approval

Before approving a foreign supplier, you must evaluate their compliance status and food safety practices. The evaluation should consider:

• FDA compliance history: Check for warning letters, import alerts, recalls, or other FDA actions
• Food safety procedures: Review the supplier's HACCP plan, preventive controls, or equivalent food safety system
• Third-party certifications:GFSI-benchmarked certifications (SQF, BRC, FSSC 22000) can support supplier evaluation
• Previous performance: If you have history with the supplier, consider their track record

Ongoing Re-evaluation

You must re-evaluate your foreign suppliers at least every three years, or more frequently if circumstances warrant. Triggers for earlier re-evaluation include:

• New information about potential hazards
• FDA warning letters or import alerts affecting the supplier
• Recalls or food safety incidents
• Changes in the supplier's operations or processes
• Audit findings requiring corrective action

Supplier Non-Compliance

When verification activities reveal that a supplier is not meeting US food safety standards, you must take appropriate corrective actions:

• Investigate the cause and scope of the non-compliance
• Determine whether the food can be made safe (reprocessing, destruction)
• Require the supplier to implement corrective actions
• Increase verification activities until confidence is restored
• Discontinue use of the supplier if problems persist

What Records Must I Keep for FSVP Compliance?

FSVP requires comprehensive documentation of all activities. Proper record-keeping demonstrates compliance during FDA inspections and provides a foundation for continuous improvement.

Required Records

Record Retention

• Records must be retained for at least two years after they were created or obtained
• Records must be made available to FDA within 24 hours of request (or reasonable time frame)
• Electronic records are acceptable if they meet FDA requirements for electronic records

Who Is Exempt from FSVP Requirements?

FSVP includes several exemptions and modified requirements for certain situations. Understanding these can reduce compliance burden where appropriate.

Full Exemptions

• Juice and seafood HACCP: Products already covered by FDA juice or seafood HACCP regulations
• Low-acid canned foods: Products covered by LACF regulations
• Alcoholic beverages: Certain alcoholic beverages are exempt
• Food for personal consumption: Food not for commercial sale
• Food for research/evaluation:Non-commercial purposes

Modified Requirements

• Very small importers: Modified requirements for importers with less than $1 million in food sales plus market value of food held without sale
• Certain raw agricultural commodities:Modified requirements when supplier is subject to produce safety rule
• Dietary supplements: Modified requirements when supplier is in compliance with dietary supplement cGMP

What Are the Most Common FSVP Violations?

FDA actively enforces FSVP requirements through inspections and import screening. Understanding common violations can help you avoid them:

How Do I Implement an FSVP Program?

Use this checklist to ensure you have addressed all key FSVP requirements:

Frequently Asked Questions