Importers of food into the United States are responsible for complying with the FDA’s Foreign Supplier Verification Program (FSVP) recordkeeping requirements. Importers must maintain complete, accurate, and accessible records demonstrating that foreign-supplied foods meet U.S. safety standards.

This general guide provides practical strategies importers can use to organize, index, and maintain records so they are inspection and audit ready.

1. What Records Must Importers Maintain Under FSVP?

Source: FDA Final Rule on FSVP (21 CFR Part 1, Subpart L)
(FDA FSVP Rule)

According to the FDA, importers must maintain the following key records:

A. Hazard Analysis

Importers must document the hazard analysis for each food, including:

• Known or reasonably foreseeable hazards

• Evaluation of severity and probability

• Determination of which hazards require controls

B. Supplier Evaluation & Approval

Records must document:

• Supplier’s performance history

• Safety / regulatory history

• Third-party audits or certifications

• Approval decisions and rationale

C. Verification Activities

Depending on risk level, importers must maintain:

• Audit reports (onsite or accredited third-party)

• Certificates of Analysis

• Laboratory test results

• Reviews of supplier food-safety records

D. Corrective Actions

If a problem is identified, importers must document:

• The issue

• The response

• Follow-up verification

• Decision on whether to continue using the supplier

E. Qualified Individual Documentation

FSVP activities must be performed by a Qualified Individual (QI). Importers must maintain documentation showing the qualifications, training, or experience of the individual performing FSVP tasks.

F. Reassessments

FSVP must be reassessed at least every three years, or sooner if new hazards or supplier changes occur.

G. Importer Identification Records

Each entry must identify the FSVP importer using a valid UFI (the FDA recognizes the DUNS number as well). These records must be kept for review.

For all documentation, the importer (or an FSVP agent at Ken Lehat & Associates) must reviews and assesses the relevant documentation.  They must show, in writing, that a review of all documentation has taken place.

2. How Long Must Importers Keep FSVP Records?

• Minimum retention: 2 years for most FSVP records

• Hazard analyses & supplier evaluations: Keep for as long as they are current, plus 2 years after superseded

• Very small importers: Some records must be retained for 3 years when used to support modified requirements

• Records must remain accessible during any FDA inspection or investigation, even if the standard retention period has passed

Records must be retrievable within a reasonable timeframe (at least 24 hours upon request).

3. Record Format: What the FDA Allows

The FDA accepts:

• Original paper records

• Scanned copies or true electronic copies

• Digital records stored in secure platforms

• Signed and dated documents (initial creation + any modification)

As long as they are:

• Accurate

• Legible

• Readable

• Easily retrievable

• Protected from alteration

When requested, importers must supply an English translation.

4. Practical Tips: Organizing Records for Fast FDA Access

To help importers stay audit-ready, the following practices are highly recommended:

A. Create a Logical, Standard File Structure

For each supplier and product, keep folders labeled clearly.  Titles should include the supplier’s name, product name or category, date, and type of document. For example, the document could be titled, “ABC Company_Black Pepper_ 1.10.2025_Flow Chart.”  The document itself should contain a clear heading which contains the date of creation, the company name, and address.   The address and supplier name should match other relevant documents.

B. Use Consistent File Naming

Include:

• Supplier

• Product

• Document type

• Date

Example:
“ABC Foods – Sesame Seeds – Hazard Analysis – 2025-01-15.pdf”

This naming format should be used for all documents.

C. Maintain a Master Index

Importers should have a quick-reference master log listing:

• All suppliers

• Foods imported

• Status of required records

• Verification frequency

• Audit/testing dates

• Next reassessment date

This is extremely helpful when the FDA requests documents.

D. Document Decision-Making

The FDA often cares why you made a decision as much as what you decided.
Record:

• Approval rationale

• Verification method selection

• Corrective-action decisions

• Supplier re-approval steps

The rationale must be recorded and documented.

E. Be Prepared for FDA’s Record Request

FSVP inspections often start with a short deadline.  Your system should allow you to retrieve any document in minutes, not days.

5. Digital vs. Paper Systems: What Works Best for Importers?

Paper Systems

Pros:

• Simple

• Low cost

Cons:

• Easily misplaced

• Hard to search

• Poor for remote audits

• Risk of physical damage

Digital Systems (Recommended for Most Importers)

Pros:

• Fast retrieval

• Searchable

• Easy to back up

• Remote access

• Compatible with FDA’s electronic expectations

Best practices for digital:

• Store PDFs to prevent accidental edits

• Implement version control

• Restrict access rights

• Use off-site/cloud backups (3-2-1 method)

• Review system annually for accuracy

Conclusion: Strong Recordkeeping Protects Importers

For importers working to meet FSVP requirements, recordkeeping is not optional. It is the core proof that the imported foods meet FDA safety standards. By building a structured, organized, and digital-ready system, importers can:

• Easily respond to FDA record requests

• Avoid warning letters and enforcement actions

• Improve supplier management

• Strengthen supply-chain transparency

Customs brokers such as Ken Lehat & Associates review FSVP records to ensure compliance.  They can serve as the FSVP agent or as a FSVP consultant.  For more information about FSVP and record keeping, please contact us directly.