Monthly digest
FDA import refusals and import alerts: September 2021
In September 2021, FDA refused 372 imported shipment lines (down 38% vs August 2021), added 24 firm listings to import alerts and removed 0; India had the most refusals and FILTHY (filthy, putrid or decomposed substance) was the most common charge (as of October 25, 2026).
Data from FDA public records, last checked .
- 372
- shipment lines refused in September 2021
- −38%
- vs August 2021
- 24
- 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 2021Countries with the most FDA refusals in September 2021
| Country | Lines | Share of month |
|---|---|---|
| India | 56 | 15% |
| China | 39 | 10% |
| Mexico | 31 | 8% |
| Vietnam | 26 | 7% |
| Brazil | 24 | 6% |
| Canada | 19 | 5% |
| Malaysia | 18 | 5% |
| Dominican Republic | 14 | 4% |
| South Korea | 14 | 4% |
| Taiwan | 13 | 3% |
Most common refusal charges in September 2021
| Charge code | Meaning | Lines |
|---|---|---|
| FILTHY | Filthy, putrid or decomposed substance | 102 |
| SALMONELLA | Salmonella | 51 |
| NUTRIT LBL | Nutrition information missing from label | 50 |
| UNAPPROVED | Unapproved new drug | 37 |
| LACKS N/C | Net quantity statement missing | 30 |
| UNSAFE COL | Color additive unsafe under section 721 | 30 |
| PESTICIDE | Pesticide chemical residue | 27 |
| LIST INGRE | Ingredients not listed | 23 |
| FSVP VIO | Importer not in compliance with FSVP | 20 |
| COLOR LBLG | Artificial coloring not declared | 19 |
Product categories refused in September 2021
| Category | Lines | Share of month |
|---|---|---|
| Fishery/Seafood Products | 72 | 19% |
| Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties | 63 | 17% |
| Vegetables and Vegetable Products (legumes, leaf and stem, fruit vegetables) | 26 | 7% |
| Macaroni and Noodle Products | 25 | 7% |
| Fruit and Fruit Products (pit, subtropical and tropical fruits) | 23 | 6% |
| Vegetables and Vegetable Products (root and tuber vegetables, fungi) | 19 | 5% |
| Snack Food Items | 18 | 5% |
| Bakery Products, Doughs, Bakery Mixes, and Icings | 17 | 5% |
| Spices, Flavors, and Salts | 17 | 5% |
| Soft Drinks and Waters | 15 | 4% |
Import alert changes in September 2021
| Alert | Covers | Added | Removed |
|---|---|---|---|
| 99-05 | Raw agricultural products for pesticides | 7 | |
| 99-23 | Produce due to contamination with human pathogens | 3 | |
| 12-03 | Imported soft cheese and soft ripened cheese from France | 2 | |
| 16-74 | Uneviscerated fish or partially eviscerated fish | 2 | |
| 45-02 | Foods containing illegal and/or undeclared colors | 2 | |
| 54-16 | Products that are marketed as foods, including products | 2 | |
| 99-19 | Food products due to the presence of Salmonella | 2 | |
| 12-10 | Cheese due to microbiological contamination | 1 | |
| 16-35 | Raw and cooked shrimp from India | 1 | |
| 24-11 | Dried peppers from Mexico | 1 | |
| 99-08 | Processed human and animal foods for pesticides | 1 |
Firms with the most FDA records in September 2021
| Firm | Country | Records in month |
|---|---|---|
| Nestle India LimitedBicholim | India | 24 |
| Monteiro Industria de Pescados LtdaItarema | Brazil | 18 |
| Hai Son Foods Co.Cam Lam District | Vietnam | 12 |
| Kingdom Honey SDN. BHD.Kuala Lumpur | Malaysia | 9 |
| Nat'L Factory Foe FoodstRiyadh | Saudi Arabia | 8 |
| Comercializadora PepsicoCiudad De Mexico | Mexico | 8 |
| ChoSung Farm .coMuan | South Korea | 6 |
| Rac Exportadora SRLSabaneta | Dominican Republic | 5 |
| Haoliyou(shanghai)Food CoShanghai | China | 5 |
| Unilever Brasil IndustrialPouso Alegre | Brazil | 5 |
Questions about September 2021
- How many shipments did FDA refuse in September 2021?
- FDA refused 372 imported food shipment lines in September 2021, compared with 602 in August 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 September 2021?
- In September 2021, the countries with the most refused shipment lines were India (56), China (39) and Mexico (31).
- Which firms were added to FDA import alerts in September 2021?
- 24 firm listings were added to FDA import alerts in September 2021, most of them on Import Alert 99-05 (7), Import Alert 99-23 (3) and Import Alert 12-03 (2). Firms with the most FDA records among those active in the month include Nestle India Limited, MONTEIRO INDUSTRIA DE PESCADOS LTDA and Hai Son Foods Co.. The alert changes are in the table on this page.
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