Violation Code: 3300
FDA Violation
Charge Code: ALLERGEN
Violation Details
- Violation Code (ASC ID)
- 3300
- Charge Code
- ALLERGEN
- Description
- the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).
- Legal Section
- 403(w) 801(a)(3); Misbranding
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Nestle India Limited | Bicholim, INDIA | 87 |
| 2 | Samyang Foods Co Ltd | Seoul, SOUTH KORE | 76 |
| 3 | FarmGroup | Barnaul, RUSSIA | 58 |
| 4 | Lotte Wellfood Co., Ltd. (Yangsan Factory) | Yangsan, SOUTH KORE | 29 |
| 5 | INGAPAN SLU | Lugo, SPAIN | 27 |
| 6 | Santa Helena Industria de Alimentos S.A. | Ribeirao Preto, BRAZIL | 27 |
| 7 | NEVA CONFECTIONERY | Sankt-Peterburg, RUSSIA | 26 |
| 8 | Laboratoires Pronutri | Carros CEDEX, FRANCE | 26 |
| 9 | Maabarot Products Ltd. | Ma'Abarot, ISRAEL | 24 |
| 10 | Jiangmen Ziqiao Food Ltd. | Taishan, CHINA | 22 |
| 11 | Challouf Est. For Trading & Industry | Beyrouth, LEBANON | 21 |
| 12 | Gwalia Sweets Pvt Ltd | Ahmedabad, INDIA | 20 |
| 13 | NESTLE INDIA LIMITED | AHMEDABAD, INDIA | 20 |
| 14 | Efe Lokum Sekerleme Insaat Sanayi | Gaziantep, TURKEY | 19 |
| 15 | Huychun (Thailand) | Nakornpatom, THAILAND | 17 |
| 16 | SO SHAPE SAS | Paris, FRANCE | 16 |
| 17 | TRUE HERBS | Michoacan, MEXICO | 16 |
| 18 | Nestle India Limited - Moga Factory | Atari, INDIA | 16 |
| 19 | ARTYNNOVA REPOSTERIA SL | Sevilla, SPAIN | 16 |
| 20 | GM FOOD LIMITED | San Po Kong, HONG KONG | 15 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/15/2026 | CAKE WITHOUT CUSTARD OR CREAM FILLING 03RGT01 | |
| 1/15/2026 | CAKE WITHOUT CUSTARD OR CREAM FILLING 03RGT01 | |
| 1/15/2026 | CAKE WITHOUT CUSTARD OR CREAM FILLING 03RGT01 | |
| 1/15/2026 | CAKE WITHOUT CUSTARD OR CREAM FILLING 03RGT01 | |
| 1/15/2026 | CAKE WITHOUT CUSTARD OR CREAM FILLING 03RGT01 | |
| 1/15/2026 | TEA, LIQUID 31KHT20 | |
| 1/15/2026 | CAKE WITHOUT CUSTARD OR CREAM FILLING 03RGT01 | |
| 1/15/2026 | CAKE WITHOUT CUSTARD OR CREAM FILLING 03RGT01 | |
| 1/13/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | TRUE HERBSMEXICO |
| 1/13/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | TRUE HERBSMEXICO |
| 1/13/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | TRUE HERBSMEXICO |
| 1/13/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | TRUE HERBSMEXICO |
| 1/13/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | TRUE HERBSMEXICO |
| 1/13/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | TRUE HERBSMEXICO |
| 1/13/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | TRUE HERBSMEXICO |
Frequently Asked Questions
What is FDA violation code 3300?
3300 is an FDA violation code that indicates: "the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).". This violation is based on 403(w) 801(a)(3); Misbranding of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3300?
According to FDA Import Refusal data, there have been 2466 import refusals issued for violation code 3300, affecting 839 unique firms.
When was the most recent refusal for violation 3300?
The most recent import refusal for violation 3300 was on January 15, 2026.
What products are commonly refused for violation 3300?
Products commonly refused under violation 3300 include: CAKE WITHOUT CUSTARD OR CREAM FILLING. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3300?
Violation code 3300 is based on 403(w) 801(a)(3); Misbranding of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This section of the law establishes requirements that imported products must meet to be allowed entry into the United States.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.