The file is organised by food and by supplier
The single most useful structural decision an importer can make is to build the FSVP file the way it will be requested: one file per foreign supplier, subdivided by food. Investigators typically ask about a specific product from a specific facility, and a file organised by shipment date or by purchase order forces you to assemble the answer under time pressure.
21 CFR Part 1 Subpart L requires that records be made available promptly to FDA for inspection and copying, and that records be in English or accompanied by an English translation. An electronic file that can be produced from any location is generally easier to satisfy this with than a physical binder at one office.
The documents that are typically requested
The specific request varies with the food and the supplier, but the following set covers most of what is asked for. Each item should exist as a dated, signed or otherwise attributable record rather than as an assertion in an email.
- Written FSVP procedures, including how you determine and conduct verification activities
- A hazard analysis for each food from each foreign supplier, identifying known or reasonably foreseeable hazards and whether each requires a control
- The evaluation of the foreign supplier — its food safety performance and compliance history, and the risk posed by the food
- Documentation of the verification activities performed, such as onsite audit reports, sampling and testing results, or reviews of the supplier's food safety records
- The written determination and justification where you selected something other than an annual onsite audit for a hazard with serious adverse health consequences
- Corrective action records where a supplier's performance or compliance status changed
- Evidence that a qualified individual performed the FSVP activities
- Records of the importer identification submitted at entry, including the DUNS number
Where importers most often come apart
Three failure patterns recur. The first is a single generic hazard analysis covering an entire product category rather than each food from each supplier, which does not match what the rule contemplates.
The second is verification activity that is not proportionate to the hazard. Where there is a reasonable probability that exposure to a hazard will result in serious adverse health consequences or death, and the foreign supplier controls that hazard, an annual onsite audit is generally required unless you document an adequate written determination that other activities provide adequate assurance. Substituting a certificate of analysis without that written determination is a recurring observation.
The third is an entity mismatch. The FSVP importer is the U.S. owner or consignee of the food at the time of entry, or where there is none, the U.S. agent or representative of the foreign owner who has confirmed in writing that it will serve as importer. A customs broker filing your entry is generally not your FSVP importer, and an incorrect importer identification transmitted at entry creates problems that have nothing to do with the quality of your program.
Exemptions worth confirming before you build
Subpart L includes exemptions and modified requirements. Seafood subject to Part 123 and juice subject to Part 120 are generally exempt from FSVP for hazards controlled under those rules, because separate importer verification obligations apply there instead. Certain food contact substances, certain research or evaluation quantities, and food from suppliers in countries whose food safety systems FDA has officially recognised or determined to be equivalent carry different treatment.
Confirming exemption status before building a program is not an attempt to avoid obligations. It prevents you from constructing an FSVP for a product where a different verification framework is the one you will actually be inspected against.
Primary sources
Go to the source rather than relying on this summary. Regulation text and agency guidance are the authority; this page is an interpretation of them.
- 21 CFR Part 1 Subpart L — Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
- 21 CFR Part 123 Subpart A — importer verification for fish and fishery products
- 21 CFR Part 1 Subpart I — Prior Notice of Imported Food