FDA refusal charge NO PROCESS: no process filing
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The NO PROCESS charge appeared in 934 FDA import refusals between 2020 and 2026 — 3.5% 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, Mexico, India. The most-affected product category is Vegetables and Vegetable Products. Volume in 2025 was up 61% on 2024.
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What FDA's charge says
NO PROCESS 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 the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
NO PROCESS refusals by year
| Year | Refusals | YoY | |
|---|---|---|---|
| 2020 | 105 | — | |
| 2021 | 134 | +27.6% | |
| 2022 | 96 | -28.4% | |
| 2023 | 116 | +20.8% | |
| 2024 | 123 | +6.0% | |
| 2025 | 198 | +61.0% | |
| 2026 | 162 | — | YTD |
| Total | 934 |
Origins most often refused under NO PROCESS
| # | Origin country | Refusals |
|---|---|---|
| 1 | China | 125 |
| 2 | Mexico | 67 |
| 3 | India | 63 |
| 4 | South Korea | 43 |
| 5 | Egypt | 38 |
| 6 | Canada | 31 |
| 7 | Taiwan | 31 |
| 8 | Japan | 30 |
| 9 | Vietnam | 30 |
| 10 | Thailand | 28 |
| 11 | Guatemala | 26 |
| 12 | Italy | 23 |
| 13 | Turkey | 20 |
| 14 | Brazil | 18 |
| 15 | Philippines | 16 |
| 16 | Spain | 16 |
| 17 | Jordan | 15 |
| 18 | United Kingdom | 15 |
| 19 | Honduras | 14 |
| 20 | United States | 14 |
| 21 | Jamaica | 12 |
| 22 | Yemen | 12 |
| 23 | France | 11 |
| 24 | Myanmar | 11 |
| 25 | Poland | 11 |
| 26 | Portugal | 11 |
| 27 | Colombia | 9 |
| 28 | Pakistan | 9 |
| 29 | Nigeria | 8 |
| 30 | Syria | 8 |
Product categories refused under NO PROCESS
| # | Product category | Refusals |
|---|---|---|
| 1 | Vegetables and Vegetable Products | 199 |
| 2 | Fruit and Fruit Products | 158 |
| 3 | Multiple Food Dinners, Gravies, Sauces, and Specialties (Total Diet) | 89 |
| 4 | Milk, Butter, and Dried Milk Products | 86 |
| 5 | Fishery/Seafood Products | 71 |
| 6 | Dressings and Condiments | 60 |
| 7 | Soft Drinks and Waters | 49 |
| 8 | Bakery Products, Doughs, Bakery Mixes, and Icings | 23 |
| 9 | Coffee and Tea | 23 |
| 10 | Filled Milk and Imitation Milk Products | 16 |
| 11 | Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans | 15 |
| 12 | Snack Food Items (Flour, Meal, or Vegetable Base) | 14 |
| 13 | Spices, Flavors, and Salts | 14 |
| 14 | Whole Grains, Milled Grain Products, and Starch | 14 |
| 15 | Baby (Infant and Junior) Food Products | 13 |
Latest refusals citing NO PROCESS
- SCS-5183735-7 SYRUPS AND MOLASSES, N.E.C.From Canada, Food Sweeteners (Nutritive). filthingredients not listedno process filingno manufacturer name+2 more
- KM6-3686478-7 SAUCES, N.E.C.From India, Multiple Food Dinners, Gravies, Sauces, and Specialties (Total Diet). filthno food-canning registrationno process filing
- B4S-1015932-3 RELISH, FRUIT BASED RELISHFrom India, Dressings and Condiments. no food-canning registrationno process filing
- BNI-0150218-4 MAYONNAISEFrom Dominican Republic, Dressings and Condiments. no process filing
- BNI-0149625-4 NAVY (WHITE) BEANS (BAKED BEANS, PORK & BEANS), IN SAUCEFrom South Africa, Vegetables and Vegetable Products. no net quantitynutrition labelingno process filing
- KM6-3684761-8 TAMARIND, DRIED OR PASTEFrom Pakistan, Fruit and Fruit Products. filthno process filing
- 918-5456115-5 HERBALS & BOTANICALS (NOT TEAS), N.E.C.From Mexico, Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. no food-canning registrationno process filing
- AMG-0181053-4 MUSHROOMS AND OTHER FUNGI PRODUCTS, BROKEN OR KIBBLED, N.E.C.From Italy, Vegetables and Vegetable Products. no process filing
- KM6-3687741-7 MULTIPLE FOOD SPECIALITIES, SIDE DISHES AND DESSERTS, N.E.C.From India, Multiple Food Dinners, Gravies, Sauces, and Specialties (Total Diet). no process filing
- 9DH-0080372-1 NONCARBONATED SOFT DRINK, N.E.C.From Indonesia, Soft Drinks and Waters. no net quantityno food-canning registrationno process filing
- 9AR-0447184-3 STRAWBERRY JUICE, BERRY JUICE OR CONCENTRATESFrom Thailand, Fruit and Fruit Products. unsafe color additiveingredients not listedno net quantitynot in English+4 more
- BNI-0150355-4 RICE, PROCESSED (PACKAGED) N.E.C.From South Africa, Whole Grains, Milled Grain Products, and Starch. pesticide residueno process filing
- 9LB-0006896-8 TZAHP CHOY (CHINESE CANNED SWEET PICKLES MADE FROM MIXED VEGETABLES) (MIXED VEGETABLES)From Jordan, Vegetables and Vegetable Products. no food-canning registrationno process filingunsafe color additive
- CIU-4202359-2 TAMARIND (SUBTROPICAL/TROPICAL FRUIT PULP)From Canada, Fruit and Fruit Products. filthnot in Englishno process filing
- BDD-0733969-6 NOODLES AND NOODLE PRODUCTS, N.E.C.From Philippines, Macaroni and Noodle Products. unsafe color additivecolor not declaredlabelingno process filing
- 83U-1461218-0 PEPPER SAUCE (HOT, MILD, ETC.)From Mexico, Dressings and Condiments. no process filing
- SCS-8130531-7 MIXED FRUIT (BABY)From United Kingdom, Baby (Infant and Junior) Food Products. no process filing
- DM0-1034263-0 HALF AND HALF (MILK AND CREAM)From Mexico, Milk, Butter, and Dried Milk Products. no process filing
- ENS-0103435-6 MILK, PLAINFrom Poland, Milk, Butter, and Dried Milk Products. no common namelabelingnutrition labelingno process filing
- KM6-3681261-2 MIXED VEGETABLES, N.E.C.From India, Vegetables and Vegetable Products. poisonous or deleterious substanceno food-canning registrationno process filing
About NO PROCESS
What does the FDA import refusal charge NO PROCESS mean?
FDA uses NO PROCESS for: no process filing. Its published charge language reads: “The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.”
Is NO PROCESS a food safety finding?
No. NO PROCESS 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 NO PROCESS?
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.