Process and registration in US Food Imports — FDA Import Refusals

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Process and registration appeared in 4,314 FDA import refusals between 2020 and 2026 — 16.7% of the 25,860 refusals that identify a hazard. 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 notifications by year

YearNotificationsof which border rejectionsYoY
2020 384 384
2021 603 603 +57.0%
2022 571 571 -5.3%
2023 490 490 -14.2%
2024 601 601 +22.7%
2025 964 964 +60.4%
2026 701 701 YTD
Total4,314

Origins most cited for Process and registration

#Origin countryNotifications
1 India 791
2 Mexico 680
3 China 337
4 Malaysia 204
5 Canada 202
6 South Korea 153
7 United Kingdom 133
8 Turkey 120
9 Guatemala 109
10 Japan 77
11 Vietnam 76
12 Thailand 74
13 Brazil 66
14 Germany 57
15 United States 57
16 Taiwan 53
17 Spain 52
18 Italy 51
19 Egypt 46
20 Nigeria 46
21 El Salvador 44
22 Colombia 42
23 Philippines 41
24 Sri Lanka 36
25 Australia 33
26 Indonesia 33
27 Pakistan 32
28 Honduras 30
29 Senegal 30
30 France 26

Product categories where Process and registration appears

#Product categoryNotifications
1Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties for Humans2,185
2Vegetables and Vegetable Products408
3Fishery/Seafood Products242
4Fruit and Fruit Products239
5Dietary Conventional Foods and Meal Replacements216
6Multiple Food Dinners, Gravies, Sauces, and Specialties (Total Diet)128
7Milk, Butter, and Dried Milk Products102
8Soft Drinks and Waters97
9Bakery Products, Doughs, Bakery Mixes, and Icings80
10Coffee and Tea71
11Spices, Flavors, and Salts71
12Dressings and Condiments66
13Baby (Infant and Junior) Food Products65
14Whole Grains, Milled Grain Products, and Starch47
15Snack Food Items (Flour, Meal, or Vegetable Base)45

Recent Process and registration notifications

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.