How often must an FSVP importer reevaluate a foreign supplier?

Promptly whenever it becomes aware of new information about the evaluation factors, and in any case at the end of any 3-year period without a reevaluation, under 21 CFR 1.505(c).

Does a supplier being added to an import alert require an FSVP reevaluation?

FDA's 2023 FSVP guidance gives a supplier's placement on an import alert as an example of new information, and says the importer should promptly reevaluate the supplier and decide whether to obtain the food elsewhere until the reevaluation is complete.

Does a reevaluation for new information reset the 3-year clock?

Yes, in effect. 21 CFR 1.505(c)(2) applies only when you have not reevaluated within a 3-year period, so a documented reevaluation under 1.505(c)(1) starts a new period.

What must I document after an FSVP reevaluation?

The reevaluation itself and, if concerns changed, your determination on whether to continue importing the food from the supplier and whether to change verification activities, plus any actions you take, signed and dated.

Can someone else reevaluate my foreign supplier for me?

Yes, an entity other than the foreign supplier may perform the reevaluation using a qualified individual, if you review and assess it and document that review, under 21 CFR 1.505(d).

Guide

When to reevaluate a foreign supplier under FSVP

Updated October 22, 20267 min read6 primary sources

Under 21 CFR 1.505(c), an FSVP importer must promptly reevaluate a food and its foreign supplier whenever it becomes aware of new information about the factors in the original evaluation, such as the supplier being placed on an FDA import alert or receiving a warning letter, and must reevaluate at the end of any 3-year period in which it has not done so. Each reevaluation, and the decision on whether to keep importing and whether to change verification activities, must be documented.

Key facts

Regulation: 21 CFR 1.505(c)(1) and (c)(2)
Trigger 1: New information about the evaluation factors: reevaluate promptly
Trigger 2: End of any 3-year period without a reevaluation
Must decide and document: Whether to continue importing; whether verification activities change
Examples FDA gives: Import alert listing, warning letter, outbreak, failed verification

What does 21 CFR 1.505(c) require?

“(1) Except as specified in paragraph (d) of this section, you must promptly reevaluate the concerns associated with the factors in paragraph (a)(1) of this section when you become aware of new information about these factors, and the reevaluation must be documented. If you determine that the concerns associated with importing a food from a foreign supplier have changed, you must promptly determine (and document) whether it is appropriate to continue to import the food from the foreign supplier and whether the supplier verification activities conducted under § 1.506 or § 1.511(c) need to be changed.”

21 CFR 1.505(c)(1)Read it on eCFR

“(2) If at the end of any 3-year period you have not reevaluated the concerns associated with the factors in paragraph (a)(1) of this section in accordance with paragraph (c)(1) of this section, you must reevaluate those concerns and take other appropriate actions, if necessary, in accordance with paragraph (c)(1). You must document your reevaluation and any subsequent actions you take in accordance with paragraph (c)(1).”

21 CFR 1.505(c)(2)Read it on eCFR

The factors are the same ones the original evaluation covered: the hazard analysis, who controls the hazards, the supplier's food safety practices, its FDA compliance information and its food safety history (1.505(a)(1)). See FSVP supplier evaluation: what FDA requires.

What counts as new information that triggers a reevaluation?

FDA's January 2023 FSVP guidance (Question E.9) gives examples, and FDA's warning letters show others it treated as changed concerns:

Examples of new information

Event	Example	Source
Supplier placed on an import alert	FDA lists the supplier on a red list for the food you buy	FSVP guidance, Question E.9
Supplier receives an FDA warning letter	A warning letter about significant violations of the preventive controls or produce safety rules	FSVP guidance, Question E.9
Outbreak linked to a previously unknown hazard	A hazard not previously associated with the food causes a foodborne illness outbreak	FSVP guidance, Question E.9
Verification shows a failure	Your audit, testing or records review shows the supplier failed to control a hazard	FSVP guidance, Question E.9
Recall of the supplier's food	FDA cited an importer that kept importing products containing a recalled ingredient without documenting a determination	Warning letter CMS 711329 (Oct 9, 2025)
Positive laboratory result	FDA cited an importer that did not reevaluate after a private laboratory result positive for Listeria monocytogenes	Warning letter CMS 681282 (Aug 28, 2024)

An FDA refusal of the supplier's food can also be new information, because the supplier's food safety history in 1.505(a)(1)(iii)(C) includes results from testing foods for hazards. See FDA import refusal: what happens next.

How quickly is promptly?

The regulation does not set a number of days. FDA's guidance focuses on awareness: because FDA posts warning letters, import alerts, inspection classifications, outbreak information and recalls on its website, it says importers should maintain an awareness of relevant new information about the foods they import and their suppliers by frequently checking for new information that FDA posts.

When the new information is an import alert, the guidance says to promptly reevaluate the supplier to determine the relevance to the food you import and whether you need to obtain the food from a different supplier, either permanently or until the reevaluation is complete.

How does the 3-year reevaluation deadline work?

Section 1.505(c)(2) applies only if you have not reevaluated during a 3-year period. A documented reevaluation done because of new information under (c)(1) therefore also counts, and the next 3-year deadline runs from it. FDA's guidance states the practical effect plainly: you must reevaluate the food and foreign supplier at least every 3 years even if you do not become aware of new information.

Track the date per food and supplier pair, not per supplier: the FSVP is kept for each food from each foreign supplier.

What should a reevaluation record contain?

The date and what prompted it: the new information, or the 3-year deadline.
The factors reviewed again, including a fresh check of FDA records (import alerts, warning letters, refusals, inspections and recalls) with the date of each check.
Whether the concerns changed, and if so the determination on continuing to import from the supplier.
Whether verification activities, or their frequency, change.
Any corrective action taken under 1.508, such as pausing the supplier.
The qualified individual's signature and date (1.503, 1.510(a)(2)).

Another entity, other than the foreign supplier, may perform the reevaluation using a qualified individual, as long as you review, assess and document it (1.505(d)).

Do very small importers have to reevaluate?

Very small importers following the modified requirements in 21 CFR 1.512 are not required to comply with 1.505. Instead they obtain written assurance from the supplier before importing and at least every 2 years, and document their very small importer status annually by December 31. An importer that is not a very small importer but buys from certain small foreign suppliers under 1.512(c) must still reevaluate the supplier's compliance history on new information and at least every 3 years.

Frequently asked questions

How often must an FSVP importer reevaluate a foreign supplier?: Promptly whenever it becomes aware of new information about the evaluation factors, and in any case at the end of any 3-year period without a reevaluation, under 21 CFR 1.505(c).
Does a supplier being added to an import alert require an FSVP reevaluation?: FDA's 2023 FSVP guidance gives a supplier's placement on an import alert as an example of new information, and says the importer should promptly reevaluate the supplier and decide whether to obtain the food elsewhere until the reevaluation is complete.
Does a reevaluation for new information reset the 3-year clock?: Yes, in effect. 21 CFR 1.505(c)(2) applies only when you have not reevaluated within a 3-year period, so a documented reevaluation under 1.505(c)(1) starts a new period.
What must I document after an FSVP reevaluation?: The reevaluation itself and, if concerns changed, your determination on whether to continue importing the food from the supplier and whether to change verification activities, plus any actions you take, signed and dated.
Can someone else reevaluate my foreign supplier for me?: Yes, an entity other than the foreign supplier may perform the reevaluation using a qualified individual, if you review and assess it and document that review, under 21 CFR 1.505(d).

Sources

Every legal and FDA-process claim above is cited to a primary source. Access dates show when each page was read.

0121 CFR 1.505 (eCFR)eCFR · accessed October 22, 2026
0221 CFR 1.512 (eCFR)eCFR · accessed October 22, 2026
03FDA FSVP Guidance for Industry (January 2023), Question E.9FDA · accessed October 22, 2026
04FDA: FSMA Final Rule on Foreign Supplier Verification ProgramsFDA · accessed October 22, 2026
05FDA warning letter CMS 711329 (October 9, 2025)FDA · accessed October 22, 2026
06FDA warning letter CMS 681282 (August 28, 2024)FDA · accessed October 22, 2026

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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.