What triggers an FSVP audit?

The FDA selects importers for FSVP inspection on a risk and routine basis; there is no warning requirement. Because inspections are records-based, readiness is about maintaining the program continuously, not preparing once a notice arrives.

Is an FSVP audit the same as a factory inspection?

No. An FSVP inspection reviews the importer’s written program and records, usually remotely. A supplier audit — verifying the foreign facility itself — may be one of the verification activities inside your FSVP, but the FSVP inspection targets your documentation.

Who has to have an FSVP?

The U.S. importer of FDA-regulated food, defined as the U.S. owner or consignee at entry (or a designated U.S. agent if there is none). The obligation cannot be shifted to the customs broker.

Can I reduce FSVP requirements if I'm small?

Possibly. Very small importers and importers of food from certain small suppliers qualify for modified requirements, but only if they meet the rule’s size definitions and keep the required documentation. A clean FSVP is built before the inspector calls, not during the email exchange. Reidel Law Firm helps importers build and maintain FSVP programs that hold up to FDA review, on flat-fee terms. Get an import compliance memo.

INTERNATIONAL TRADE LAW

FSVP Compliance: Surviving an FDA Importer Audit

Schuyler 'Rocky' Reidel July 17, 2023 4 min read

An FSVP audit is the FDA’s check that you, the U.S. importer, have a written Foreign Supplier Verification Progra