FDA refusal charge MFR INSAN: insanitary plant

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The MFR INSAN charge appeared in 831 FDA import refusals between 2020 and 2026 — 4.3% of the 19,123 refusals that identify a hazard. The origins cited most often are India, Mexico, Indonesia. The most-affected product category is Fishery/Seafood Products. Volume in 2025 was up 270% on 2024.

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What FDA's charge says

MFR INSAN 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)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.

Sections 801(a)(1); INSANITARY MANUFACTURING, PROCESSING OR PACKING

MFR INSAN refusals by year

YearRefusalsYoY
202035—
202156+60.0%
202248-14.3%
202367+39.6%
202489+32.8%
2025329+269.7%
2026207—YTD
Total831

Origins most often refused under MFR INSAN

#Origin countryRefusals
1India188
2Mexico95
3Indonesia87
4Tanzania70
5Guatemala38
6Greece36
7South Korea36
8Myanmar26
9Thailand23
10Vietnam18
11China16
12Nigeria14
13Brazil13
14Canada13
15Taiwan13
16United Arab Emirates12
17Chile10
18Colombia10
19Lebanon10
20Egypt9
21Ghana9
22Turkey9
23Zambia9
24Philippines8
25Israel7
26Jordan7
27Liberia5
28Netherlands5
29Ecuador4
30Sri Lanka4

Product categories refused under MFR INSAN

#Product categoryRefusals
1Fishery/Seafood Products326
2Vegetables and Vegetable Products113
3Fruit and Fruit Products91
4Snack Food Items (Flour, Meal, or Vegetable Base)90
5Nuts and Edible Seeds59
6Spices, Flavors, and Salts48
7Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans29
8Bakery Products, Doughs, Bakery Mixes, and Icings21
9Candy Without Chocolate, Candy Specialties, and Chewing Gum21
10Cheese and Cheese Products10
11Cereal Preparations, Breakfast Foods5
12Multiple Food Dinners, Gravies, Sauces, and Specialties (Total Diet)5
13Macaroni and Noodle Products3
14Chocolate and Cocoa Products2
15Whole Grains, Milled Grain Products, and Starch2

Latest refusals citing MFR INSAN

About MFR INSAN

What does the FDA import refusal charge MFR INSAN mean?

FDA uses MFR INSAN for: insanitary plant. Its published charge language reads: “The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.”

Is MFR INSAN a food safety finding?

Yes. This site counts MFR INSAN 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 MFR INSAN?

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.