What an FDA Inspector Actually Checks During an FSVP Audit

Most food importers know the Foreign Supplier Verification Program (FSVP) exists. Few know what an inspector actually looks at when they show up. This post pulls back the curtain.

Understanding the audit process helps you prepare — not scramble.

The Legal Starting Point: 21 CFR 1.510

Under FDA regulations, importers must have a Foreign Supplier Verification Program in place before bringing food into the United States. Section 1.510 specifically governs what documentation an FDA investigator can request at the port of entry or during a facility inspection.

The short version: if you import food, you must have records. If you cannot produce them on demand, you are out of compliance.

What the Inspector Asks to See First

The first thing an FDA investigator requests is your FSVP file for the specific food and supplier being reviewed. This is not a general company audit. It is supplier-specific and product-specific.

They want to see:

• The name and address of your foreign supplier

• Documentation that you identified the hazards in that food

• Evidence you evaluated the supplier's food safety performance

• Records showing you approved that supplier before importing

Missing any one of these is a red flag.

Hazard Analysis: The Core of Every FSVP File

Inspectors spend significant time on your hazard analysis. This document must reflect the food, the supplier's country, the processes involved, and the intended consumer.

They look for:

• Biological, chemical, and physical hazards identified by name

• A written determination of whether each hazard requires a control

• The basis for that determination

A generic hazard analysis copied from a template rarely holds up. Investigators know what a real analysis looks like. Yours should be specific to your product.

Supplier Verification Activities

Once the hazard analysis checks out, investigators move to verification. Your file must show you actually confirmed the supplier controls those hazards.

Acceptable verification activities include:

• Onsite audits of the foreign facility

• Review of the supplier's food safety records

• Third-party audit reports

• Testing of food or food ingredients

The activity must match the risk. High-risk foods (ready-to-eat products, for example) require more rigorous verification than low-risk shelf-stable items.

Corrective Actions and Reassessments

Investigators also check whether you have a corrective action procedure on file. If a supplier fails a verification activity, what did you do? Did you document it? Did you reassess the supplier?

FSVP requires periodic reassessment at least every three years or sooner if conditions change. Inspectors look for dated reassessment records. An FSVP file that has not been touched since it was created is a compliance problem waiting to happen.

Qualified Individual Sign-Off

Every FSVP must be developed and reviewed by a qualified individual. That person must have the education, training, or experience to perform food safety analysis.

Inspectors verify this. They may ask for credentials or training records. If the person who signed your FSVP cannot demonstrate competency, the entire program is at risk.

Get Your FSVP Plan Reviewed Before the Inspector Does

An FDA audit does not have to be a surprise. A well-documented, supplier-specific FSVP file gives you a defensible position from day one. Our team reviews FSVP plans for importers across every product category — and we know exactly what investigators look for.

Do not wait for a warning letter to find the gaps.

Get your FSVP plan reviewed today: https://www.usimports.us/services