Monthly digest
FDA import refusals and import alerts: September 2022
In September 2022, FDA refused 675 imported shipment lines (down 8% vs August 2022), added 27 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 26, 2026).
Data from FDA public records, last checked .
- 675
- shipment lines refused in September 2022
- −8%
- vs August 2022
- 27
- firm listings added to import alerts
- 0
- firm listings removed
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.
October 2022Countries with the most FDA refusals in September 2022
Most common refusal charges in September 2022
| Charge code | Meaning | Lines |
|---|---|---|
| UNSAFE COL | Color additive unsafe under section 721 | 131 |
| UNAPPROVED | Unapproved new drug | 108 |
| FILTHY | Filthy, putrid or decomposed substance | 106 |
| NO ENGLISH | Required label information not in English | 103 |
| NUTRIT LBL | Nutrition information missing from label | 87 |
| LACKS N/C | Net quantity statement missing | 82 |
| LIST INGRE | Ingredients not listed | 66 |
| COLOR LBLG | Artificial coloring not declared | 49 |
| LABELING | Fair Packaging and Labeling Act | 42 |
| SALMONELLA | Salmonella | 40 |
Product categories refused in September 2022
| Category | Lines | Share of month |
|---|---|---|
| Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties | 139 | 21% |
| Color Additives for Foods, Drugs, and Cosmetics | 96 | 14% |
| Fruit and Fruit Products (pit, subtropical and tropical fruits) | 59 | 9% |
| Fishery/Seafood Products | 43 | 6% |
| Snack Food Items | 38 | 6% |
| Vegetables and Vegetable Products (legumes, leaf and stem, fruit vegetables) | 30 | 4% |
| Vegetables and Vegetable Products (root and tuber vegetables, fungi) | 25 | 4% |
| Cheese and Cheese Products | 24 | 4% |
| Dressings and Condiments | 24 | 4% |
| Bakery Products, Doughs, Bakery Mixes, and Icings | 18 | 3% |
Import alert changes in September 2022
| Alert | Covers | Added | Removed |
|---|---|---|---|
| 16-81 | Seafood products due to the presence of Salmonella | 4 | |
| 23-14 | Food products due to the presence of mycotoxins | 3 | |
| 99-39 | Imported food products that appear to be misbranded | 3 | |
| 45-02 | Foods containing illegal and/or undeclared colors | 2 | |
| 99-05 | Raw agricultural products for pesticides | 2 | |
| 99-08 | Processed human and animal foods for pesticides | 2 | |
| 99-19 | Food products due to the presence of Salmonella | 2 | |
| 99-45 | Food products that are or contain an unsafe food additive | 2 | |
| 16-124 | Aquaculture seafood products due to unapproved drugs | 1 | |
| 16-74 | Uneviscerated fish or partially eviscerated fish | 1 | |
| 21-07 | Tamarind and tamarind products (fresh, frozen, dried, and/or | 1 | |
| 54-16 | Products that are marketed as foods, including products | 1 | |
| 99-22 | Foods containing undeclared major food allergens or foods | 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 September 2022
| Firm | Country | Records in month |
|---|---|---|
| Brow Code Pty LtdMolendinar | Australia | 94 |
| Agroalimentos Fresh Harvest SA de CVCuliacan | Mexico | 23 |
| Fabrica Pepsico Mexicali S de RL de CV Planta Mexicali IIMexicali | Mexico | 22 |
| Vgarden Ltd.Gan Shmuel | Israel | 22 |
| Bambino Agro Ind.Ltd.Secunderabad | India | 17 |
| Hekma Center Ltd.Ar'Ara | Israel | 12 |
| Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga | Mexico | 10 |
| Najeeb Thawabi &CO LTDAmman | Jordan | 10 |
| Tonic Life S de RLIrapuato | Mexico | 8 |
| Laboratorios Pisa SA de CVIztacalco | Mexico | 8 |
Questions about September 2022
- How many shipments did FDA refuse in September 2022?
- FDA refused 675 imported food shipment lines in September 2022, compared with 730 in August 2022. 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 September 2022?
- In September 2022, the countries with the most refused shipment lines were Mexico (156), Australia (95) and India (78).
- Which firms were added to FDA import alerts in September 2022?
- 27 firm listings were added to FDA import alerts in September 2022, most of them on Import Alert 16-81 (4), Import Alert 23-14 (3) and Import Alert 99-39 (3). Firms with the most FDA records among those active in the month include BROW CODE PTY LTD, Agroalimentos Fresh Harvest SA de CV and FABRICA PEPSICO MEXICALI S DE RL DE CV PLANTA MEXICALI II. The alert changes are in the table on this page.
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