Monthly digest
FDA import refusals and import alerts: December 2018
December 1, 2018 to December 31, 2018
In December 2018, FDA refused 522 imported shipment lines (down 26% vs November 2018), added 39 firm listings to import alerts and removed 0; Mexico 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 .
- 522
- shipment lines refused in December 2018
- −26%
- vs November 2018
- 39
- firm listings added to import alerts
- 0
- firm listings removed
November 2018
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 2019Countries with the most FDA refusals in December 2018
Shipment lines refused, by country of origin. Each country links to its full refusal history.
| Country | Lines | Share of month |
|---|---|---|
| Mexico | 126 | 24% |
| India | 82 | 16% |
| Indonesia | 53 | 10% |
| China | 40 | 8% |
| Japan | 19 | 4% |
| Philippines | 19 | 4% |
| Costa Rica | 16 | 3% |
| South Korea | 15 | 3% |
| Vietnam | 15 | 3% |
| Peru | 13 | 2% |
Most common refusal charges in December 2018
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 | 95 |
| NUTRIT LBL | Nutrition information missing from label | 76 |
| UNSAFE COL | Color additive unsafe under section 721 | 71 |
| PESTICIDE | Pesticide chemical residue | 66 |
| UNSFDIETSP | Dietary ingredient without safety assurance | 52 |
| NO ENGLISH | Required label information not in English | 40 |
| COLOR LBLG | Artificial coloring not declared | 38 |
| LACKS N/C | Net quantity statement missing | 33 |
| NO PROCESS | No scheduled process filed | 33 |
| SALMONELLA | Salmonella | 33 |
Product categories refused in December 2018
| Category | Lines | Share of month |
|---|---|---|
| Fishery/Seafood Products | 77 | 15% |
| Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties | 77 | 15% |
| Vegetables and Vegetable Products (legumes, leaf and stem, fruit vegetables) | 66 | 13% |
| Snack Food Items | 34 | 7% |
| Bakery Products, Doughs, Bakery Mixes, and Icings | 30 | 6% |
| Fruit and Fruit Products (berries, citrus and core fruits) | 28 | 5% |
| Spices, Flavors, and Salts | 27 | 5% |
| Macaroni and Noodle Products | 25 | 5% |
| Fruit and Fruit Products (pit, subtropical and tropical fruits) | 20 | 4% |
| Multiple Food Dinners, Gravies, Sauces, and Specialties | 19 | 4% |
Import alert changes in December 2018
39 firm listings added and 0 removed. Alerts with changes, most changes first.
| Alert | Covers | Added | Removed |
|---|---|---|---|
| 99-05 | Raw agricultural products for pesticides | 15 | |
| 45-02 | Foods containing illegal and/or undeclared colors | 5 | |
| 99-39 | Imported food products that appear to be misbranded | 4 | |
| 54-16 | Products that are marketed as foods, including products | 2 | |
| 99-08 | Processed human and animal foods for pesticides | 2 | |
| 99-19 | Food products due to the presence of Salmonella | 2 | |
| 16-105 | Fish and fishery products from specific | 1 | |
| 16-125 | Refrigerated (not frozen with proper labeling) raw fish | 1 | |
| 16-127 | All seafood due to chloramphenicol | 1 | |
| 16-129 | Seafood products due to nitrofurans | 1 | |
| 21-17 | Papaya from Mexico | 1 | |
| 23-14 | Food products due to the presence of mycotoxins | 1 | |
| 99-21 | Food products containing undeclared added sulfiting agents | 1 | |
| 99-22 | Foods containing undeclared major food allergens or foods | 1 | |
| 99-32 | Human and animal food products from foreign establishments | 1 |
Firms with the most FDA records in December 2018
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 |
|---|---|---|
| Amc Line ExpressBekasi | Indonesia | 38 |
| Hacienda de ChichimequillasFresnillo | Mexico | 24 |
| Comercializadora PepsicoCiudad De Mexico | Mexico | 23 |
| Irex de Costa Rica S.ABelen | Costa Rica | 14 |
| Vidal Foods S.A.C.Lima | Peru | 12 |
| Nestle India LimitedBicholim | India | 10 |
| Ciemme Alimentari S.r.l.Barletta | Italy | 9 |
| Delimex de MexicoTlaquepaque | Mexico | 8 |
| M/S Jhaveri IndustriesUmargam | India | 7 |
| Sgb & SonsAnand 38800 (Guji) | India | 7 |
Questions about December 2018
- How many shipments did FDA refuse in December 2018?
- FDA refused 522 imported food shipment lines in December 2018, compared with 703 in November 2018. 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 2018?
- In December 2018, the countries with the most refused shipment lines were Mexico (126), India (82) and Indonesia (53).
- Which firms were added to FDA import alerts in December 2018?
- 39 firm listings were added to FDA import alerts in December 2018, most of them on Import Alert 99-05 (15), Import Alert 45-02 (5) and Import Alert 99-39 (4). Firms with the most FDA records among those active in the month include Amc Line Express, HACIENDA DE CHICHIMEQUILLAS and COMERCIALIZADORA PEPSICO. The alert changes are in the table on this page.
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