Monthly digest
FDA import refusals and import alerts: December 2017
December 1, 2017 to December 31, 2017
In December 2017, FDA refused 519 imported shipment lines (up 10% vs November 2017), added 64 firm listings to import alerts and removed 0; India had the most refusals and FILTHY (filthy, putrid or decomposed substance) was the most common charge (as of October 26, 2026).
Data from FDA public records, last checked .
- 519
- shipment lines refused in December 2017
- +10%
- vs November 2017
- 64
- firm listings added to import alerts
- 0
- firm listings removed
November 2017
Counts can rise after publication because FDA's refusal data includes only final actions and is updated weekly. We recompute every month on each run.
January 2018Countries with the most FDA refusals in December 2017
Shipment lines refused, by country of origin. Each country links to its full refusal history.
| Country | Lines | Share of month |
|---|---|---|
| India | 93 | 18% |
| Mexico | 69 | 13% |
| China | 42 | 8% |
| Brazil | 30 | 6% |
| South Korea | 28 | 5% |
| Indonesia | 27 | 5% |
| Italy | 25 | 5% |
| United Kingdom | 15 | 3% |
| Thailand | 12 | 2% |
| Canada | 11 | 2% |
Most common refusal charges in December 2017
FDA records one or more charge codes on every refused line, so counts can exceed the number of lines.
| Charge code | Meaning | Lines |
|---|---|---|
| FILTHY | Filthy, putrid or decomposed substance | 102 |
| PESTICIDE | Pesticide chemical residue | 100 |
| NUTRIT LBL | Nutrition information missing from label | 97 |
| NO ENGLISH | Required label information not in English | 69 |
| LACKS N/C | Net quantity statement missing | 55 |
| UNSAFE COL | Color additive unsafe under section 721 | 49 |
| SALMONELLA | Salmonella | 42 |
| LIST INGRE | Ingredients not listed | 41 |
| NCONTACT | No U.S. adverse event contact on supplement label | 31 |
| UNAPPROVED | Unapproved new drug | 31 |
Product categories refused in December 2017
| Category | Lines | Share of month |
|---|---|---|
| Fishery/Seafood Products | 102 | 20% |
| Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties | 94 | 18% |
| Vegetables and Vegetable Products (legumes, leaf and stem, fruit vegetables) | 53 | 10% |
| Bakery Products, Doughs, Bakery Mixes, and Icings | 35 | 7% |
| Fruit and Fruit Products (pit, subtropical and tropical fruits) | 35 | 7% |
| Spices, Flavors, and Salts | 22 | 4% |
| Whole Grains, Milled Grain Products, and Starch | 20 | 4% |
| Candy without Chocolate, Candy Specialties, and Chewing Gum | 19 | 4% |
| Milk, Butter, and Dried Milk Products | 15 | 3% |
| Vegetables and Vegetable Products (root and tuber vegetables, fungi) | 14 | 3% |
Import alert changes in December 2017
64 firm listings added and 0 removed. Alerts with changes, most changes first.
| Alert | Covers | Added | Removed |
|---|---|---|---|
| 99-05 | Raw agricultural products for pesticides | 19 | |
| 99-08 | Processed human and animal foods for pesticides | 10 | |
| 45-02 | Foods containing illegal and/or undeclared colors | 9 | |
| 99-37 | Low-acid canned foods and acidified foods without filed | 6 | |
| 16-81 | Seafood products due to the presence of Salmonella | 5 | |
| 16-120 | Fish and fishery products from foreign processors (mfrs.) | 2 | |
| 99-39 | Imported food products that appear to be misbranded | 2 | |
| 16-04 | Seafood products that appear to be misbranded | 1 | |
| 16-124 | Aquaculture seafood products due to unapproved drugs | 1 | |
| 16-131 | Aquacultured, shrimp, dace, and eel from China and Hong Kong | 1 | |
| 16-137 | Seafood due to viral contamination | 1 | |
| 16-35 | Raw and cooked shrimp from India | 1 | |
| 21-07 | Tamarind and tamarind products (fresh, frozen, dried, and/or | 1 | |
| 21-17 | Papaya from Mexico | 1 | |
| 40-05 | Adulterated and misbranded infant formula | 1 | |
| 99-22 | Foods containing undeclared major food allergens or foods | 1 | |
| 99-23 | Produce due to contamination with human pathogens | 1 | |
| 99-32 | Human and animal food products from foreign establishments | 1 |
Firms with the most FDA records in December 2017
Counts are FDA records dated in the month (refusals, import alert listings and other events), not a ranking of quality.
| Firm | Country | Records in month |
|---|---|---|
| Jw Pharmaceutical CorporationSeoul | South Korea | 13 |
| Estrella Nueva S. de R. L. de C. V.Mexicali | Mexico | 12 |
| Brassuco Industria de Produtos Alimenticios LTDAItu | Brazil | 11 |
| Harihar Foods Pvt LtdAhmedabad | India | 10 |
| Jairamdass KhushiramNavi Mumbai | India | 10 |
| Desai Brothers LimitedPune | India | 10 |
| ATRIUM Innovations inc.Quebec | Canada | 7 |
| Alimentos Prosalud SABarranca | Costa Rica | 7 |
| Tianjin Hongbin Agricultural Technology Development Co.,Ltd.Tianjin | China | 7 |
| Azienda Agricola D'Assisi di FraPonte | Italy | 7 |
Questions about December 2017
- How many shipments did FDA refuse in December 2017?
- FDA refused 519 imported food shipment lines in December 2017, compared with 473 in November 2017. Counts can rise after publication because FDA's refusal data includes only final actions and is updated weekly.
- Which countries had the most FDA refusals in December 2017?
- In December 2017, the countries with the most refused shipment lines were India (93), Mexico (69) and China (42).
- Which firms were added to FDA import alerts in December 2017?
- 64 firm listings were added to FDA import alerts in December 2017, most of them on Import Alert 99-05 (19), Import Alert 99-08 (10) and Import Alert 45-02 (9). Firms with the most FDA records among those active in the month include JW PHARMACEUTICAL CORPORATION, Estrella Nueva S. de R. L. de C. V. and Brassuco Industria de Produtos Alimenticios LTDA. The alert changes are in the table on this page.
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