Answers · Updated

FSVP requirements for US food importers: who must comply and what the file must contain

Short answer

Under the Foreign Supplier Verification Program rule (21 CFR Part 1 Subpart L, sections 1.500 to 1.514), the FSVP importer, meaning the US owner or consignee of the food at entry or a designated US agent, must for each food and foreign supplier: analyse hazards (1.504), evaluate and approve the supplier (1.505), conduct and document verification activities (1.506), reevaluate promptly on new information and at least every 3 years (1.505(c)), take corrective action when needed (1.508), be identified at entry (1.509) and keep the records for at least 2 years (1.510).

What the FSVP file must contain

  • A written hazard analysis for each type of food, by a qualified individual or reviewed from another entity (1.504).
  • A documented evaluation of the hazard, the entity controlling it and the supplier's performance, including FDA warning letters or import alerts, plus a documented approval (1.505).
  • Written procedures to import only from approved suppliers and documented verification activities: onsite audit, sampling and testing, records review or another appropriate activity (1.506).
  • An initial and at least annual onsite audit when a supplier-controlled hazard could cause serious adverse health consequences or death, unless you document that another activity is adequate (1.506(d)).
  • Documented reevaluations and corrective actions (1.505(c), 1.508), and signed, dated records available to FDA (1.510).

Who is exempt

21 CFR 1.501 lists exemptions, including juice and seafood from suppliers subject to the HACCP rules in parts 120 and 123, food imported for research or evaluation, food for personal consumption, certain alcoholic beverages, food transshipped or imported for processing and export, and certain meat, poultry and egg products regulated by USDA. Dietary supplements and very small importers have modified requirements (1.511, 1.512). The FSVP check audits the file; it does not decide exemptions.

Sources

Frequently Asked Questions

Who is the FSVP importer?
The US owner or consignee of the food at the time of entry. If there is none, the foreign owner or consignee must designate a US agent or representative as the importer (21 CFR 1.500 and 1.509(b)).
How often must a foreign supplier be reevaluated under FSVP?
Promptly when you learn new information about the hazard or the supplier, and at least once in any 3-year period, with the reevaluation documented (21 CFR 1.505(c)).
Is an annual onsite audit always required?
Only when a hazard controlled by the foreign supplier could cause serious adverse health consequences or death. Even then you may use another verification activity if you document why it gives adequate assurance (21 CFR 1.506(d)).
How long must FSVP records be kept?
At least 2 years after you created or obtained them, and records about procedures for at least 2 years after their use is discontinued. Offsite records must be retrievable within 24 hours (21 CFR 1.510).

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