Top Countries for FDA Import Refusals — Ranked by Import Division

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What these division codes mean
DNEI
Division of Northeast Imports.
DSEI
Division of Southeast Imports.
DWCI
Division of West Coast Imports.
DSWI
Division of Southwest Imports — the Mexican land border.
DNBI
Division of North Border Imports — the Canadian land border.

Get the weekly summary of new FDA import refusals

Refusals by year

YearRefusalsYoY
2022 3,412 +17.9%
2023 3,516 +3.0%
2024 3,984 +13.3%
2025 5,625 +41.2%
2026 3,736 YTD

Import divisions, 2025 (latest complete year)

#Import divisionRefusals% of total
1DNEI1,44625.7%
2DSEI1,38524.6%
3DWCI1,16220.7%
4DSWI97217.3%
5DNBI66011.7%

Full 2025 breakdown →

About FDA import refusals

What is an FDA import refusal?

An FDA import refusal is an entry that FDA examined, or sampled, and refused admission into US commerce — most often because it appeared adulterated or misbranded under the Federal Food, Drug, and Cosmetic Act. It is an entry-level administrative action, not a finding of guilt and not an adjudication; the importer may recondition, re-export or destroy the goods.

What is the difference between the import division and the country of origin?

The import division is one of FDA's own operating divisions that processed the entry and issued the refusal. The country of origin is where the refused product was produced or shipped from. These pages rank import divisions by the number of refusals they issued, separately from the origin-country breakdown.

Do import refusals keep unsafe food out of the United States?

Yes, that is their purpose: refusing an entry at the border stops a non-compliant consignment from reaching US commerce. Not every refusal is a safety finding, though — close to three in ten are labelling or registration failures rather than a hazard in the product itself, which is why this site counts hazard and paperwork refusals separately.