FDA refusal charge 807REFUSAL: listing refusal

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The 807REFUSAL charge appeared in 68 FDA import refusals between 2020 and 2026 — 0.3% of all 26,358 US import refusals. The charge is a process, registration or approval failure, not a contaminant or pathogen found in the product. The origins cited most often are China, South Korea, Brazil. The most-affected product category is Fishery/Seafood Products. Volume in 2025 was up 150% on 2024.

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What FDA's charge says

807REFUSAL is the code FDA prints on a refusal; below is the charge language FDA publishes for it, quoted from its charge table, with the sections of the FD&C Act it cites.

The food is subject to refusal of admission pursuant to Section 807 in that the foreign factory, warehouse, or other establishment of which the owner, operator, or agent in charge, or the government of the foreign country, refuses to permit entry of United States inspectors or other individuals duly designated by the Secretary, upon request, to inspect such factory, warehouse, or other establishment.

Sections 807(b)

807REFUSAL refusals by year

YearRefusalsYoY
20203—
20211-66.7%
20224+300.0%
20246—
202515+150.0%
202639—YTD
Total68

Origins most often refused under 807REFUSAL

#Origin countryRefusals
1China29
2South Korea25
3Brazil4
4Mexico3
5Taiwan3
6Bulgaria1
7France1
8Oman1
9Vietnam1

Product categories refused under 807REFUSAL

#Product categoryRefusals
1Fishery/Seafood Products13
2Vegetables and Vegetable Products12
3Snack Food Items (Flour, Meal, or Vegetable Base)10
4Fruit and Fruit Products6
5Spices, Flavors, and Salts5
6Candy Without Chocolate, Candy Specialties, and Chewing Gum4
7Bakery Products, Doughs, Bakery Mixes, and Icings3
8Macaroni and Noodle Products3
9Multiple Food Dinners, Gravies, Sauces, and Specialties (Total Diet)3
10Vegetable Oils (Includes Olive Oil)2
11Egg and Egg Products1
12Filled Milk and Imitation Milk Products1
13Food Additives - for Human Use1
14Food Sweeteners (Nutritive)1
15Nuts and Edible Seeds1

Latest refusals citing 807REFUSAL

About 807REFUSAL

What does the FDA import refusal charge 807REFUSAL mean?

FDA uses 807REFUSAL for: listing refusal. Its published charge language reads: “The food is subject to refusal of admission pursuant to Section 807 in that the foreign factory, warehouse, or other establishment of which the owner, operator, or agent in charge, or the government of the foreign country, refuses to permit entry of United States inspectors or other individuals duly designated by the Secretary, upon request, to inspect such factory, warehouse, or other establishment.”

Is 807REFUSAL a food safety finding?

No. 807REFUSAL is a process, registration or approval failure: the charge records a missing filing, registration, approval or process control, not a contaminant or pathogen found in the product. This site counts a refusal citing it alone with paperwork. It can still mean the product cannot lawfully be sold in the US.

What happens to a shipment refused under 807REFUSAL?

Under section 801(a) of the FD&C Act a refused entry has to be exported or destroyed, normally within 90 days of the notice of refusal. Bringing a product into compliance, for instance by relabelling, is something the importer asks FDA for before the decision is final. The notice itself and FDA's guidance govern a particular case; this page describes the published data and is not legal advice.