FSVP Importer Checklist: Avoid the Top 5 Violations

What Is FSVP and Who Does It Apply To?

The Foreign Supplier Verification Program (FSVP) is a rule under the FDA Food Safety Modernization Act (FSMA), codified at 21 CFR Part 1, Subpart L. It requires U.S. importers of food for human and animal consumption to perform risk-based activities to verify that their foreign suppliers are producing food in a manner that meets U.S. safety standards — specifically, the preventive controls and produce safety standards under FSMA.

The FSVP importer is defined as the U.S. owner or consignee of the food at the time of entry into the United States, or if there is no U.S. owner or consignee, the U.S. agent or representative of the foreign owner or consignee. This is different from the customs Importer of Record, though they may be the same entity.

The FSVP Compliance Checklist

Use this checklist to assess your FSVP compliance. Each item corresponds to a regulatory requirement:

Top 5 FSVP Violations

Based on FDA inspection data, these are the most frequently cited FSVP violations:

1. No Hazard Analysis (21 CFR §1.504)

The most common violation. Many importers assume their foreign suppliers have already addressed hazards and fail to conduct their own analysis. FSVP requires the importer to independently identify hazards, not merely rely on the supplier's assessment.

2. Inadequate Supplier Evaluation (21 CFR §1.505)

Importers that don't evaluate their suppliers' food safety practices, or rely solely on certifications without verifying compliance, are frequently cited. FDA expects risk-based evaluation that may include on-site audits for high-risk foods.

3. Missing Corrective Actions (21 CFR §1.508)

When a supplier is found non-compliant, the importer must take corrective actions — which can include discontinuing the supplier. Many importers lack documented corrective action procedures entirely.

4. Incomplete Records (21 CFR §1.510)

FSVP records must be comprehensive and readily available. FDA inspectors frequently find missing hazard analyses, outdated supplier evaluations, or records that cannot be produced within the required 24-hour window.

5. Failure to Identify FSVP Importer (21 CFR §1.509)

Since May 2019, FSVP importers must provide their DUNS number at entry so FDA can identify who is responsible for FSVP compliance for each import line. Missing or incorrect DUNS numbers at entry is a growing citation.

FSVP Exemptions and Modified Requirements

Some importers qualify for modified FSVP requirements:

• Very small importers: Importers with average annual sales below $1 million (and limited food sales) have modified requirements but are not fully exempt
• Certain low-risk foods: Foods not subject to preventive controls or produce safety rules may have simplified requirements
• VQIP participants: Importers participating in the Voluntary Qualified Importer Program may have expedited entry but still need a full FSVP

Note: Even with modified requirements, you must still have a hazard analysis and identify yourself as the FSVP importer at entry.

Next Steps for FSVP Compliance

If your FSVP program has gaps — or you don't have one at all — take these steps immediately:

1. Conduct a hazard analysis for every food product you import
2. Evaluate every foreign supplier's food safety practices
3. Implement risk-based supplier verification activities
4. Document corrective action procedures
5. Ensure your DUNS number is provided at every import entry
6. Organize all records for immediate FDA access

Assurentry's compliance team can help you build or audit your FSVP program to ensure it withstands FDA inspection. Contact us for a free compliance assessment.