FDA refusal charge INSANITARY: insanitary conditions
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The INSANITARY charge appeared in 311 FDA import refusals between 2020 and 2026 — 1.6% of the 19,123 refusals that identify a hazard. The origins cited most often are Mexico, India, El Salvador. The most-affected product category is Fishery/Seafood Products. Volume in 2025 was down 20% on 2024.
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What FDA's charge says
INSANITARY 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 article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
INSANITARY refusals by year
| Year | Refusals | YoY | |
|---|---|---|---|
| 2020 | 71 | — | |
| 2021 | 30 | -57.7% | |
| 2022 | 34 | +13.3% | |
| 2023 | 36 | +5.9% | |
| 2024 | 56 | +55.6% | |
| 2025 | 45 | -19.6% | |
| 2026 | 39 | — | YTD |
| Total | 311 |
Origins most often refused under INSANITARY
| # | Origin country | Refusals |
|---|---|---|
| 1 | Mexico | 91 |
| 2 | India | 56 |
| 3 | El Salvador | 19 |
| 4 | Vietnam | 18 |
| 5 | Canada | 9 |
| 6 | South Korea | 9 |
| 7 | China | 8 |
| 8 | Philippines | 8 |
| 9 | Thailand | 8 |
| 10 | Nicaragua | 7 |
| 11 | Tanzania | 7 |
| 12 | Jamaica | 6 |
| 13 | Honduras | 4 |
| 14 | Jordan | 4 |
| 15 | Taiwan | 4 |
| 16 | Turkey | 4 |
| 17 | United States | 4 |
| 18 | Chile | 3 |
| 19 | Costa Rica | 3 |
| 20 | Japan | 3 |
| 21 | Lebanon | 3 |
| 22 | Poland | 3 |
| 23 | Colombia | 2 |
| 24 | Ecuador | 2 |
| 25 | Ghana | 2 |
| 26 | Spain | 2 |
| 27 | Ukraine | 2 |
| 28 | Algeria | 1 |
| 29 | Argentina | 1 |
| 30 | Brazil | 1 |
Product categories refused under INSANITARY
| # | Product category | Refusals |
|---|---|---|
| 1 | Fishery/Seafood Products | 92 |
| 2 | Fruit and Fruit Products | 64 |
| 3 | Vegetables and Vegetable Products | 55 |
| 4 | Cheese and Cheese Products | 48 |
| 5 | Nuts and Edible Seeds | 13 |
| 6 | Snack Food Items (Flour, Meal, or Vegetable Base) | 8 |
| 7 | Bakery Products, Doughs, Bakery Mixes, and Icings | 5 |
| 8 | Multiple Food Dinners, Gravies, Sauces, and Specialties (Total Diet) | 5 |
| 9 | Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans | 5 |
| 10 | Candy Without Chocolate, Candy Specialties, and Chewing Gum | 4 |
| 11 | Dressings and Condiments | 3 |
| 12 | Spices, Flavors, and Salts | 3 |
| 13 | Baby (Infant and Junior) Food Products | 1 |
| 14 | Coffee and Tea | 1 |
| 15 | Egg and Egg Products | 1 |
Latest refusals citing INSANITARY
- 8TH-0052161-5 SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTSFrom India, Fishery/Seafood Products. insanitary conditions
- DK3-0793658-5 GOBYFrom Vietnam, Fishery/Seafood Products. HACCP failureinsanitary conditions
- 8NP-0813263-5 SCADFrom Vietnam, Fishery/Seafood Products. HACCP failureinsanitary conditionsSalmonella
- EVJ-1264207-3 FISH, N.E.C.From Thailand, Fishery/Seafood Products. filthHACCP failureinsanitary conditions
- 231-7579212-3 BLUEBERRIES (BERRY)From Chile, Fruit and Fruit Products. insanitary conditionsinsanitary handling
- F12-0076852-3 BLUEBERRIES (BERRY)From Chile, Fruit and Fruit Products. insanitary conditionsinsanitary plant
- 8QB-0001362-6 CHEESE PRODUCTS, STANDARDIZED, N.E.C.From Honduras, Cheese and Cheese Products. ingredients not listedinsanitary conditionsno manufacturer nameno net quantity+3 more
- 8QB-0001336-0 CHEESE PRODUCTS, STANDARDIZED, N.E.C.From Honduras, Cheese and Cheese Products. insanitary conditions
- 551-2760150-5 MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULAFrom Germany, Baby (Infant and Junior) Food Products. insanitary conditions
- SCS-7682396-9 SOFT CANDY WITH NUTS OR NUT PRODUCTS, N.E.C. (WITHOUT CHOCOLATE)From Brazil, Candy Without Chocolate, Candy Specialties, and Chewing Gum. insanitary conditionsinsanitary plant
- N56-0051180-6 HAKE, HOT SMOKED, FISHFrom Nigeria, Fishery/Seafood Products. flavor not declaredno common namelabelingnutrition labeling+6 more
- 8QB-0001363-4 CHEESE PRODUCTS, STANDARDIZED, N.E.C.From Honduras, Cheese and Cheese Products. insanitary conditionsinsanitary plantinsanitary handling
- BYX-0312282-1 CILANTRO (LEAF & STEM VEGETABLE)From Mexico, Vegetables and Vegetable Products. insanitary conditionsinsanitary plant
- KM6-3678229-4 MANGO (SUBTROPICAL AND TROPICAL FRUIT)From India, Fruit and Fruit Products. no food-canning registrationno process filingfilthinsanitary conditions
- D77-8000282-1 PERCH, FRESH WATER (YELLOW, LAKE)From Tanzania, Fishery/Seafood Products. false or misleading labelinsanitary conditionsno common nameinsanitary plant
- AVV-9997731-0 FISH, N.E.C.From Vietnam, Fishery/Seafood Products. HACCP failureinsanitary conditions
- BJG-0217520-5 CANTALOUPE (VINE FRUIT)From Mexico, Fruit and Fruit Products. insanitary conditionsSalmonella
- 8NP-0813009-2 SCADFrom Vietnam, Fishery/Seafood Products. HACCP failureinsanitary conditions
- B7E-0038513-6 CASSAVA (ROOT AND TUBER VEGETABLE)From Costa Rica, Vegetables and Vegetable Products. insanitary conditions
- 8NP-0813040-7 SCADFrom Vietnam, Fishery/Seafood Products. HACCP failureinsanitary conditions
About INSANITARY
What does the FDA import refusal charge INSANITARY mean?
FDA uses INSANITARY for: insanitary conditions. Its published charge language reads: “The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.”
Is INSANITARY a food safety finding?
Yes. This site counts INSANITARY as a hazard finding, so a refusal citing it is on the hazard side of the hazard and paperwork split, whatever else the refusal cites.
What happens to a shipment refused under INSANITARY?
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.