FSVP supplier evaluation: what FDA requires

Section 1.505(a)(1) lists four groups of factors. The table maps each one to what you would record and where the information usually comes from.

The regulation names warning letters, import alerts and other FDA compliance actions. FDA's January 2023 FSVP guidance (Question E.4) adds that you may use the FDA Data Dashboard to search for warning letters, import alerts, import refusals, recall notices, inspections and notices of suspension of facility registration. In practice, a complete compliance check covers five public record types:

A record on this list does not decide the outcome by itself. FDA's guidance says that being subject to an FDA action such as a warning letter or an import alert should not necessarily disqualify a foreign supplier, but that you should carefully consider the actions the supplier took in response. For the mechanics of the alert search, see How to check if a supplier is on an FDA import alert.

A qualified individual must develop your FSVP and perform its activities (21 CFR 1.503(a)). That person needs the education, training or experience for the task and must be able to read the records being reviewed. The qualified individual may be, but does not have to be, your employee.

Another entity, such as a consultant, may perform the evaluation for you, as long as it is not the foreign supplier itself. You then review and assess that evaluation and document your review, including that a qualified individual did the work (21 CFR 1.505(d)). The approval stays with you: FDA's guidance (Question E.8) says only the FSVP importer may approve its foreign suppliers.

• The evaluation itself (21 CFR 1.505(a)(2)).
• Your approval of the supplier, based on that evaluation (21 CFR 1.505(b)).
• Every reevaluation and any action you took after it (21 CFR 1.505(c)).
• A signature and date on FSVP records when first completed and whenever modified (21 CFR 1.510(a)(2)).

Records about your processes and procedures, including the results of evaluations, must be kept for at least 2 years after their use is discontinued, for example after you stop using that supplier or replace the evaluation with a reevaluation (21 CFR 1.510(c)(2)). Records must be made available promptly to FDA on request, and offsite records must be retrievable within 24 hours (21 CFR 1.510(b)).

FDA's FSVP rule page also notes that an FSVP is required for each food and each foreign supplier: one food from three suppliers means three FSVPs, and three foods from one supplier means three as well. A field-by-field layout is in our FSVP supplier evaluation template.

Section 1.505(c) sets two triggers. You must promptly reevaluate when you become aware of new information about the evaluation factors, and you must reevaluate at the end of any 3-year period in which you have not done so. FDA's guidance gives a supplier being placed on an import alert, or receiving a warning letter, as examples of new information. Details are in When to reevaluate a foreign supplier under FSVP.

Missing evaluations appear regularly in FDA's FSVP warning letters. In a warning letter dated October 9, 2025 (CMS 711329), FDA cited an importer under 1.505(a)(1)(iii)(B) because its approval of a supplier did not consider the supplier's history under two of the three import alerts on which the supplier was listed. More examples are in FSVP warning letters: what FDA cites.

The regulation's own consequences are in 21 CFR 1.514. Food may be refused admission under section 801(a)(3) of the FD&C Act if the importer appears not to comply with the FSVP rule, and importing food without a compliant FSVP is a prohibited act under section 301(zz). FDA can also list an importer on Import Alert 99-41, which allows detention without physical examination of the named foods.

• Juice and seafood from suppliers subject to, and in compliance with, the juice or seafood HACCP regulations (parts 120 and 123) are outside the FSVP rule (21 CFR 1.501(b)).
• Very small importers and importers of certain food from certain small foreign suppliers may follow the modified requirements in 21 CFR 1.512, which rely on written assurances instead of the full evaluation.
• Importers of certain dietary supplements and dietary supplement components follow 21 CFR 1.511.
• Food from a country whose food safety system FDA has officially recognized as comparable or equivalent may qualify for 21 CFR 1.513.

Even under 1.512(c), an importer buying from certain small foreign suppliers must still evaluate the supplier's FDA compliance history, including warning letters and import alerts, and reevaluate it on new information and every 3 years.