Using FDA import refusal data in an FSVP supplier evaluation

This guide is for US importers and their QA staff who keep a Foreign Supplier Verification Program (FSVP). It shows how to use FDA's import refusal record, as organised on this site, in the supplier evaluation the rule requires, and in the reevaluation that follows. It uses one real example throughout: vegetables from China. This is not legal advice.

What the rule asks for

The FSVP rule is 21 CFR Part 1, Subpart L. Section 1.505(a)(1) says that in approving a foreign supplier you must consider, among other things, "foreign supplier performance", including:

• "information relevant to the foreign supplier's compliance with those regulations, including whether the foreign supplier is the subject of an FDA warning letter, import alert, or other FDA compliance action related to food safety" (1.505(a)(1)(iii)(B)), and
• "the foreign supplier's food safety history, including available information about results from testing foods for hazards, audit results relating to the safety of the food, and responsiveness of the foreign supplier in correcting problems" (1.505(a)(1)(iii)(C)).

Note what the text does and does not say. It names warning letters and import alerts. It does not name import refusals. A refusal record is still information relevant to compliance and food safety history, which is why it belongs in the file. Do not tell an auditor the rule requires a refusal search by name.

Section 1.505(c) adds reevaluation. You must "promptly reevaluate" when you "become aware of new information about these factors", and you must reevaluate at least once in "any 3-year period". Both must be documented.

One more boundary matters. Under 1.502(a), FSVP covers adulteration (section 402 of the FD&C Act) and misbranding "with respect to labeling for the presence of major food allergens" (403(w)). It does not cover a missing nutrition panel. That is why the hazard/paperwork split in step 3 matters.

Step 1: Open the origin page

Start with the origin, for example China. It shows refusals for the last 12 quarters, the split between hazard and paperwork, and the categories. It tells you the context, not your supplier's record.

Step 2: Go to the origin and product category

Open the page for what you buy. China, Vegetables and Vegetable Products shows 323 refusals from 2023-Q4 to 2026-Q3. The most-cited issues are Listeria monocytogenes, filth and missing process filings.

Read the hazards as a check on your hazard analysis under 1.504. For this line, 75 refusals cite Listeria, 114 cite filth or insanitary conditions and 63 cite pesticide residues. Of the 75 Listeria refusals, 40 are enoki mushrooms. If you import enoki from China and your hazard analysis does not treat Listeria as a hazard requiring a control, the refusal record is a reason to revisit it.

Step 3: Split hazard from paperwork

Every page counts hazard refusals (something found in or wrong with the food) apart from paperwork refusals (labelling, registration, filing). For China vegetables it is 275 hazard and 48 paperwork.

For FSVP they mean different things:

• A hazard refusal (filth, Listeria, pesticides) speaks to the supplier's food safety performance. That is what 1.505 asks you to weigh.
• An allergen labelling refusal is inside FSVP scope under 403(w). The allergens page counts it as a hazard.
• Other labelling refusals, such as nutrition facts or English text, are real compliance problems, but they are not what FSVP asks you to verify.
• An FSVP violation refusal is about the importer, not the supplier. FDA's charge text reads: the importer "is in violation of section 805". Since 2020, 411 refusals carry this charge, and 391 of them carry no hazard charge. In China vegetables, 18 of the 48 paperwork refusals are FSVP violations. The process and registration page collects them. They tell you that US buyers of this product get stopped for their own records. They say nothing about the grower.

Step 4: Check the hazard across origins

Open the hazard page for the main risk. On Listeria, China is the most-cited origin, then South Korea and Malaysia, and vegetables are the most-affected category. If you plan to qualify a second source in another country, this shows whether that moves the risk or removes it.

Step 5: Compare rates within one commodity

Where trade data exists, the commodity page gives refusals per $1 billion of US imports over three years, and ranks the origin. China, vegetables-other runs at 454.4 per $1 billion and ranks 11th of 24 origins, above 57% of them. That is mid-table: a lot of refusals, but also a lot of trade.

Compare rates only within the same commodity. Where no rate is shown, there is no trade baseline, not a clean record.

Step 6: Find your supplier's own entries

This is the step the site cannot do for you. It does not show firm names or FEI numbers. Each page lists recent refusals with the entry number, date, import division, product and charges. For firm-level history, search FDA's Data Dashboard, whose import refusal data carries the FEI number and firm legal name.

Why it matters: the 323 China vegetable refusals involve 172 different firms, and 127 of those firms appear only once. An origin figure tells you about the product. Your supplier's FEI tells you about your supplier. File both, and check import alerts and warning letters separately, since those are what 1.505 names.

Step 7: Know which division is refusing

The import division pages show which FDA division issued each refusal. China vegetables are refused mostly by the West Coast (157) and Northeast (132) divisions. If your entries go through one port region, that is where your delays will be.

Worked example: an enoki supplier in China

The record does not say "approve" or "reject". It points to what to ask for: how the supplier controls Listeria, its environmental monitoring and lot testing records, and its own FEI history of refusals and any import alert.

Pitfalls

• A refusal is not an adjudication. As every page footer says, it is "an entry-level action by FDA, not a finding of guilt". The goods may be reconditioned or re-exported.
• Counts are entries, not lines. One entry can carry many lines; the site counts it once.
• Recent periods are incomplete. The data runs to 10 September 2026. China vegetables show 24 refusals in 2026-Q3 against 42 in Q2. That is an unfinished quarter, not an improvement.
• The firm on a refusal is the one FDA recorded. Before you attribute an entry to your supplier, match the FEI, not the name.
• No rate means no baseline. It does not mean low risk.

Keep it current

Section 1.505(c) requires a prompt reevaluation when new information appears. A weekly alert on the product you import is a simple way to see that information when it arrives.