Monthly digest
FDA import refusals and import alerts: September 2023
In September 2023, FDA refused 528 imported shipment lines (up 1% vs August 2023), added 37 firm listings to import alerts and removed 0; India had the most refusals and NO ENGLISH (required label information not in English) was the most common charge (as of October 25, 2026).
Data from FDA public records, last checked .
- 528
- shipment lines refused in September 2023
- +1%
- vs August 2023
- 37
- 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 2023Countries with the most FDA refusals in September 2023
| Country | Lines | Share of month |
|---|---|---|
| India | 113 | 21% |
| Mexico | 76 | 14% |
| El Salvador | 32 | 6% |
| Pakistan | 31 | 6% |
| China | 30 | 6% |
| Canada | 27 | 5% |
| Guatemala | 19 | 4% |
| Japan | 19 | 4% |
| Italy | 16 | 3% |
| Bangladesh | 12 | 2% |
Most common refusal charges in September 2023
| Charge code | Meaning | Lines |
|---|---|---|
| NO ENGLISH | Required label information not in English | 92 |
| NUTRIT LBL | Nutrition information missing from label | 88 |
| PESTICIDE | Pesticide chemical residue | 80 |
| FILTHY | Filthy, putrid or decomposed substance | 73 |
| UNAPPROVED | Unapproved new drug | 58 |
| UNSAFE COL | Color additive unsafe under section 721 | 51 |
| LACKS N/C | Net quantity statement missing | 42 |
| SALMONELLA | Salmonella | 37 |
| LIST INGRE | Ingredients not listed | 36 |
| NO PROCESS | No scheduled process filed | 33 |
Product categories refused in September 2023
| Category | Lines | Share of month |
|---|---|---|
| Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties | 65 | 12% |
| Vegetables and Vegetable Products (legumes, leaf and stem, fruit vegetables) | 40 | 8% |
| Nuts and Edible Seeds | 39 | 7% |
| Fishery/Seafood Products | 37 | 7% |
| Bakery Products, Doughs, Bakery Mixes, and Icings | 33 | 6% |
| Whole Grains, Milled Grain Products, and Starch | 32 | 6% |
| Dietary Conventional Foods and Meal Replacements | 31 | 6% |
| Spices, Flavors, and Salts | 27 | 5% |
| Macaroni and Noodle Products | 26 | 5% |
| Snack Food Items | 26 | 5% |
Import alert changes in September 2023
| Alert | Covers | Added | Removed |
|---|---|---|---|
| 99-08 | Processed human and animal foods for pesticides | 7 | |
| 99-05 | Raw agricultural products for pesticides | 6 | |
| 99-39 | Imported food products that appear to be misbranded | 5 | |
| 99-19 | Food products due to the presence of Salmonella | 4 | |
| 16-35 | Raw and cooked shrimp from India | 3 | |
| 45-02 | Foods containing illegal and/or undeclared colors | 3 | |
| 99-22 | Foods containing undeclared major food allergens or foods | 3 | |
| 54-16 | Products that are marketed as foods, including products | 2 | |
| 21-17 | Papaya from Mexico | 1 | |
| 99-21 | Food products containing undeclared added sulfiting agents | 1 | |
| 99-37 | Low-acid canned foods and acidified foods without filed | 1 | |
| 99-46 | Imported human foods due to filth | 1 |
Firms with the most FDA records in September 2023
| Firm | Country | Records in month |
|---|---|---|
| FACEMA S.A. De C.V.San Salvador | El Salvador | 22 |
| Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga | Mexico | 22 |
| Rice Experts EnterprisesGujranwala | Pakistan | 19 |
| Comercializadora Pepsico Mexico,Ciudad De Mexico | Mexico | 18 |
| Sansyokuhin Co., Ltd.Nagoya | Japan | 12 |
| Milesh Marine Exports Pvt. Ltd.Krishna District | India | 11 |
| Vahdam Teas Pvt LtNoida | India | 11 |
| La Casa de los Aromas S.L.Novelda | Spain | 7 |
| Giovanna BeccariaMessina | Italy | 7 |
| Bambino Agro Ind.Ltd.Secunderabad | India | 6 |
Questions about September 2023
- How many shipments did FDA refuse in September 2023?
- FDA refused 528 imported food shipment lines in September 2023, compared with 524 in August 2023. 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 2023?
- In September 2023, the countries with the most refused shipment lines were India (113), Mexico (76) and El Salvador (32).
- Which firms were added to FDA import alerts in September 2023?
- 37 firm listings were added to FDA import alerts in September 2023, most of them on Import Alert 99-08 (7), Import Alert 99-05 (6) and Import Alert 99-39 (5). Firms with the most FDA records among those active in the month include FACEMA S.A. De C.V., Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco) and Rice Experts Enterprises. 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.