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FDA import refusals and import alerts: September 2022

September 1, 2022 to September 30, 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
August 2022

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 2022

Countries with the most FDA refusals in September 2022

Shipment lines refused, by country of origin. Each country links to its full refusal history.
Countries with the most FDA refusals in September 2022
CountryLinesShare of month
Mexico15623%
Australia9514%
India7812%
Israel355%
China335%
Vietnam304%
Indonesia223%
France193%
Canada173%
Zimbabwe142%

Most common refusal charges in September 2022

FDA records one or more charge codes on every refused line, so counts can exceed the number of lines.
Most common FDA refusal charges in September 2022
Charge codeMeaningLines
UNSAFE COLColor additive unsafe under section 721131
UNAPPROVEDUnapproved new drug108
FILTHYFilthy, putrid or decomposed substance106
NO ENGLISHRequired label information not in English103
NUTRIT LBLNutrition information missing from label87
LACKS N/CNet quantity statement missing82
LIST INGREIngredients not listed66
COLOR LBLGArtificial coloring not declared49
LABELINGFair Packaging and Labeling Act42
SALMONELLASalmonella40

Product categories refused in September 2022

Product categories refused in September 2022
CategoryLinesShare of month
Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties13921%
Color Additives for Foods, Drugs, and Cosmetics9614%
Fruit and Fruit Products (pit, subtropical and tropical fruits)599%
Fishery/Seafood Products436%
Snack Food Items386%
Vegetables and Vegetable Products (legumes, leaf and stem, fruit vegetables)304%
Vegetables and Vegetable Products (root and tuber vegetables, fungi)254%
Cheese and Cheese Products244%
Dressings and Condiments244%
Bakery Products, Doughs, Bakery Mixes, and Icings183%

Import alert changes in September 2022

27 firm listings added and 0 removed. Alerts with changes, most changes first.
Import alerts with listings added or removed in September 2022
AlertCoversAddedRemoved
16-81Seafood products due to the presence of Salmonella4
23-14Food products due to the presence of mycotoxins3
99-39Imported food products that appear to be misbranded3
45-02Foods containing illegal and/or undeclared colors2
99-05Raw agricultural products for pesticides2
99-08Processed human and animal foods for pesticides2
99-19Food products due to the presence of Salmonella2
99-45Food products that are or contain an unsafe food additive2
16-124Aquaculture seafood products due to unapproved drugs1
16-74Uneviscerated fish or partially eviscerated fish1
21-07Tamarind and tamarind products (fresh, frozen, dried, and/or1
54-16Products that are marketed as foods, including products1
99-22Foods containing undeclared major food allergens or foods1
99-23Produce due to contamination with human pathogens1
99-42Foods due to heavy metal (toxic element) contamination1

Firms with the most FDA records in September 2022

Counts are FDA records dated in the month (refusals, import alert listings and other events), not a ranking of quality.
Firms with the most FDA records dated in September 2022
FirmCountryRecords in month
Brow Code Pty LtdMolendinarAustralia94
Agroalimentos Fresh Harvest SA de CVCuliacanMexico23
Fabrica Pepsico Mexicali S de RL de CV Planta Mexicali IIMexicaliMexico22
Vgarden Ltd.Gan ShmuelIsrael22
Bambino Agro Ind.Ltd.SecunderabadIndia17
Hekma Center Ltd.Ar'AraIsrael12
Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De ZunigaMexico10
Najeeb Thawabi &CO LTDAmmanJordan10
Tonic Life S de RLIrapuatoMexico8
Laboratorios Pisa SA de CVIztacalcoMexico8

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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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.