Monthly digest
FDA import refusals and import alerts: December 2021
December 1, 2021 to December 31, 2021
In December 2021, FDA refused 660 imported shipment lines (up 41% vs November 2021), added 21 firm listings to import alerts and removed 0; Mexico had the most refusals and UNSAFE COL (color additive unsafe under section 721) was the most common charge (as of October 25, 2026).
Data from FDA public records, last checked .
- 660
- shipment lines refused in December 2021
- +41%
- vs November 2021
- 21
- firm listings added to import alerts
- 0
- firm listings removed
November 2021
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 2022Countries with the most FDA refusals in December 2021
Shipment lines refused, by country of origin. Each country links to its full refusal history.
Most common refusal charges in December 2021
FDA records one or more charge codes on every refused line, so counts can exceed the number of lines.
| Charge code | Meaning | Lines |
|---|---|---|
| UNSAFE COL | Color additive unsafe under section 721 | 143 |
| COLOR LBLG | Artificial coloring not declared | 125 |
| NUTRIT LBL | Nutrition information missing from label | 113 |
| NO ENGLISH | Required label information not in English | 88 |
| SALMONELLA | Salmonella | 73 |
| FILTHY | Filthy, putrid or decomposed substance | 72 |
| FSVP VIO | Importer not in compliance with FSVP | 64 |
| LACKS N/C | Net quantity statement missing | 44 |
| NO PROCESS | No scheduled process filed | 39 |
| LACKS FIRM | Manufacturer name and address missing | 37 |
Product categories refused in December 2021
| Category | Lines | Share of month |
|---|---|---|
| Snack Food Items | 109 | 17% |
| Fruit and Fruit Products (pit, subtropical and tropical fruits) | 64 | 10% |
| Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties | 63 | 10% |
| Bakery Products, Doughs, Bakery Mixes, and Icings | 42 | 6% |
| Vegetables and Vegetable Products (legumes, leaf and stem, fruit vegetables) | 42 | 6% |
| Vegetables and Vegetable Products (root and tuber vegetables, fungi) | 42 | 6% |
| Spices, Flavors, and Salts | 38 | 6% |
| Candy without Chocolate, Candy Specialties, and Chewing Gum | 38 | 6% |
| Fishery/Seafood Products | 34 | 5% |
| Soft Drinks and Waters | 29 | 4% |
Import alert changes in December 2021
21 firm listings added and 0 removed. Alerts with changes, most changes first.
| Alert | Covers | Added | Removed |
|---|---|---|---|
| 45-02 | Foods containing illegal and/or undeclared colors | 4 | |
| 99-05 | Raw agricultural products for pesticides | 3 | |
| 99-39 | Imported food products that appear to be misbranded | 3 | |
| 99-19 | Food products due to the presence of Salmonella | 2 | |
| 12-10 | Cheese due to microbiological contamination | 1 | |
| 21-11 | Ackees due to Hypoglycin A | 1 | |
| 25-05 | Dried fungus (mushrooms) from Hong Kong and PROC for filth | 1 | |
| 31-03 | Guanabana (soursop) | 1 | |
| 54-16 | Products that are marketed as foods, including products | 1 | |
| 99-08 | Processed human and animal foods for pesticides | 1 | |
| 99-21 | Food products containing undeclared added sulfiting agents | 1 | |
| 99-23 | Produce due to contamination with human pathogens | 1 | |
| 99-42 | Foods due to heavy metal (toxic element) contamination | 1 |
Firms with the most FDA records in December 2021
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 |
|---|---|---|
| Comercializadora PepsicoCiudad De Mexico | Mexico | 104 |
| Ghrawi Group For Chocolate & Sweets Co., SalKfarshima | Lebanon | 23 |
| KFI Inc.Mississauga | Canada | 22 |
| Rogelio Carreno FloresLa Resolana | Mexico | 18 |
| martinex expor produce s.a. de c.v.San Nicolas De Los Garza | Mexico | 17 |
| Maria De Jesus Osuna PradoMazatlan | Mexico | 15 |
| Adf Foods LimitedNadiad | India | 15 |
| Elite Strauss GroupNazrat | Israel | 13 |
| Mahashian Di Hatti Pvt. Ltd.Gurgram | India | 10 |
| Agroindustrias Lacteas Los Quesos De Oriente S.A. de C.V.Acajutla | El Salvador | 10 |
Questions about December 2021
- How many shipments did FDA refuse in December 2021?
- FDA refused 660 imported food shipment lines in December 2021, compared with 467 in November 2021. 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 2021?
- In December 2021, the countries with the most refused shipment lines were Mexico (196), India (111) and China (53).
- Which firms were added to FDA import alerts in December 2021?
- 21 firm listings were added to FDA import alerts in December 2021, most of them on Import Alert 45-02 (4), Import Alert 99-05 (3) and Import Alert 99-39 (3). Firms with the most FDA records among those active in the month include COMERCIALIZADORA PEPSICO, GHRAWI GROUP FOR CHOCOLATE & SWEETS CO., SAL and KFI Inc.. The alert changes are in the table on this page.
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