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 | NESTLE INDIA LIMITED | AHMEDABAD, INDIA | 20 |
| 13 | Gwalia Sweets Pvt Ltd | 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 | ARTYNNOVA REPOSTERIA SL | Sevilla, SPAIN | 16 |
| 18 | GM FOOD LIMITED | San Po Kong, HONG KONG | 15 |
| 19 | Holw El Sham | Cairo, EGYPT | 15 |
| 20 | Nestle India Ltd | New Delhi, INDIA | 14 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/23/2025 | MACAROON,PREPARED DRY COOKIE, BISCUITS AND WAFER MIXES WITH MILK OR EGGS 03KYH11 | |
| 12/23/2025 | CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) 33SYY99 | |
| 12/23/2025 | CAKE DOUGH OR BATTER WITHOUT CUSTARD OR CREAM FILLING 03TYY01 | |
| 12/23/2025 | CAKE DOUGH OR BATTER WITHOUT CUSTARD OR CREAM FILLING 03TYY01 | |
| 12/23/2025 | CAKE DOUGH OR BATTER WITHOUT CUSTARD OR CREAM FILLING 03TYY01 | |
| 12/23/2025 | OTHER FRUIT AND FRUIT PRODUCTS, DRIED AND PASTE, N.E.C. 22HYH99 | |
| 12/17/2025 | MILK AND CREAM, N.E.C. 09CHT99 | |
| 12/8/2025 | DIETARY CONVENTIONAL FOODS, N.E.C. 41YYY99 | BIOCOL PHARMA, LDAPORTUGAL |
| 12/4/2025 | CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH NUTS OR NUT PRODUCTS (WITHOUT CHOCOLATE) 33GGT05 | HELMI FOOD MATERIALSJORDAN |
| 11/25/2025 | NONCARBONATED SOFT DRINK, N.E.C. 29ACE99 | Huychun (Thailand)THAILAND |
| 11/25/2025 | NONCARBONATED SOFT DRINK, N.E.C. 29ACE99 | Huychun (Thailand)THAILAND |
| 11/25/2025 | NONCARBONATED SOFT DRINK, N.E.C. 29ACE99 | Huychun (Thailand)THAILAND |
| 11/25/2025 | NONCARBONATED SOFT DRINK, N.E.C. 29ACE99 | Huychun (Thailand)THAILAND |
| 11/25/2025 | NONCARBONATED SOFT DRINK, N.E.C. 29ACE99 | Huychun (Thailand)THAILAND |
| 11/24/2025 | SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C. 29YGY99 | Sejun Food Co., LtdSOUTH KORE |
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 2436 import refusals issued for violation code 3300, affecting 834 unique firms.
When was the most recent refusal for violation 3300?
The most recent import refusal for violation 3300 was on December 23, 2025.
What products are commonly refused for violation 3300?
Products commonly refused under violation 3300 include: MACAROON,PREPARED DRY COOKIE, BISCUITS AND WAFER MIXES WITH MILK OR EGGS, CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE), CAKE DOUGH OR BATTER 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.