Last refresh: . 26,528 refusals since 2020-01-01.

Process and registration in US Food Imports — FDA Import Refusals

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Process and registration appeared in 4,447 FDA import refusals between 2020 and 2026 — 16.8% of all 26,528 US import refusals. The charge is a labelling or registration failure, not a hazard found in the product. The origins cited most often are India, Mexico, China. The most-affected product category is Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans. Volume in 2025 was up 60% on 2024.

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Process and registration refusals by year

YearRefusalsYoY
2020 384 —
2021 603 +57.0%
2022 571 -5.3%
2023 490 -14.2%
2024 601 +22.7%
2025 964 +60.4%
2026 834 — YTD
Total4,447

Origins most cited for Process and registration

#Origin countryRefusals
1 India 839
2 Mexico 688
3 China 343
4 Canada 205
5 Malaysia 204
6 South Korea 154
7 United Kingdom 134
8 Turkey 121
9 Guatemala 113
10 Japan 82
11 Vietnam 79
12 Thailand 76
13 Brazil 66
14 Germany 59
15 United States 58
16 Taiwan 55
17 Italy 53
18 Spain 52
19 Sri Lanka 50
20 Colombia 46
21 Egypt 46
22 Nigeria 46
23 El Salvador 45
24 Philippines 43
25 Indonesia 34
26 Australia 33
27 Pakistan 33
28 Honduras 30
29 Senegal 30
30 France 27

Product categories where Process and registration appears

#Product categoryRefusals
1Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans2,263
2Vegetables and Vegetable Products417
3Fishery/Seafood Products252
4Fruit and Fruit Products243
5Dietary Conventional Foods and Meal Replacements220
6Multiple Food Dinners, Gravies, Sauces, and Specialties (Total Diet)132
7Milk, Butter, and Dried Milk Products105
8Soft Drinks and Waters100
9Bakery Products, Doughs, Bakery Mixes, and Icings81
10Spices, Flavors, and Salts74
11Coffee and Tea71
12Dressings and Condiments69
13Baby (Infant and Junior) Food Products67
14Whole Grains, Milled Grain Products, and Starch48
15Snack Food Items (Flour, Meal, or Vegetable Base)45

FDA charge codes in Process and registration

CodeWhat it meansRefusals
UNAPPROVEDunapproved new drug2,425
NO PROCESSno process filing944
NEEDS FCEno food-canning registration509
FSVP VIOFSVP violation417
NOT LISTEDestablishment not listed206
SUPPL GMPsupplement GMP failure165
FRNMFGREGforeign plant not registered135
INADPRCCTLinadequate process control131
MFRHACCPHACCP failure112
807REFUSALlisting refusal68
LACK NOTIFno premarket notification52
NEEDS ACIDno acidified-food filing50

Recent Process and registration refusals

About Process and registration

Process-registration charges are paperwork failures in the systems meant to keep food safe, not findings against the product itself. They cover a foreign supplier's failure to meet Foreign Supplier Verification Program obligations, a facility that has not registered with FDA, and — for canned, acidified, juice and seafood processors — a missing or inadequate scheduled process or HACCP filing under 21 CFR Parts 108, 120 and 123. They concentrate in low-acid canned goods, juice and seafood, where a documented process is the actual safety control.

Which FDA import refusals does this page count?

Every entry FDA refused that cites this hazard among its charge codes. A single entry can carry more than one charge, so an entry refused for both a pathogen and a labelling defect is counted on both the relevant hazard page and, separately, in the hazard/paperwork split shown on the leaderboard.

What happens when this hazard is found in a shipment?

The entry is refused admission into US commerce. The importer must recondition the shipment (where that is possible), export it out of the United States, or have it destroyed under FDA supervision. Repeated findings against one shipper or product can lead FDA to place them on an Import Alert, which subjects future shipments to detention without physical examination.

Where does this data come from?

The public FDA Import Refusal Report, refetched weekly. Counts are per entry (consignment), so one entry listing several charge codes for the same hazard is counted once.