Violation Code: 3843
FDA Violation
Charge Code: TP NO SE
Violation Details
- Violation Code (ASC ID)
- 3843
- Charge Code
- TP NO SE
- Description
- This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be misbranded under section 903(a)(6) of the FD&C Act in that a notice or other information respecting it was not provided as required by section 905(j).
- Legal Section
- 801(a)(3);903(a)(6);MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | BRITISH AMERICAN TOBACCO | Malmo, SWEDEN | 747 |
| 2 | Swedish Match Ab | Stockholm, SWEDEN | 441 |
| 3 | APRES NICOTINE AB | Vetlanda, SWEDEN | 343 |
| 4 | HABIT FACTORY IN SWEDEN AB | Arsta, SWEDEN | 254 |
| 5 | Skruf Snus Ab | Stockholm, SWEDEN | 222 |
| 6 | NGP TOBACCO APS | Norager, DENMARK | 222 |
| 7 | Luna Corporate | Suchy Las, POLAND | 200 |
| 8 | YOIK AB | Gemla, SWEDEN | 185 |
| 9 | GUANGDONG TOULANG INTERNATIONALLOGISTICS CO., LTD | Shenzhen, CHINA | 167 |
| 10 | Fiedler & Lundgren Ab | Malmo, SWEDEN | 154 |
| 11 | LIW INNOVATION AB | Hokerum, SWEDEN | 144 |
| 12 | CBI SRO | Teplice, CZECH REPU | 137 |
| 13 | CHAINPOP AB | Goteborg, SWEDEN | 137 |
| 14 | HELIX SWEDEN AB | Helsingborg, SWEDEN | 125 |
| 15 | 77 GROUP SP. Z O.O. | Suchy Las, POLAND | 114 |
| 16 | SHENZHEN JILIAN INTERNATIONAL FREIGHT FORWARDING C | Shenzhen, CHINA | 103 |
| 17 | SHENZHEN GOLDREAMS TECHNOLOGY CO | Shenzhen, CHINA | 101 |
| 18 | Swedish Match Ab | Stockholm, DENMARK | 93 |
| 19 | MICROZERO AB | Goteborg, SWEDEN | 80 |
| 20 | Shenzhen Joecig Technology Co Ltd | Shenzhen, CHINA | 75 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/31/2025 | NICOTINE POUCH 98NBA11 | BAS NORDIC ABSWEDEN |
| 12/31/2025 | NICOTINE POUCH 98NCA11 | HELIX SWEDEN ABSWEDEN |
| 12/31/2025 | NICOTINE POUCH 98NCA11 | HELIX SWEDEN ABSWEDEN |
| 12/31/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | PHILIP MORRIS ABSWEDEN |
| 12/30/2025 | NICOTINE POUCH 98NCA11 | Swedish Match AbSWEDEN |
| 12/30/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | BRITISH AMERICAN TOBACCOSWEDEN |
| 12/30/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | BRITISH AMERICAN TOBACCOSWEDEN |
| 12/30/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | BRITISH AMERICAN TOBACCOSWEDEN |
| 12/29/2025 | NICOTINE POUCH 98NCA11 | YOIK ABSWEDEN |
| 12/29/2025 | NICOTINE POUCH 98NCA11 | YOIK ABSWEDEN |
| 12/29/2025 | NICOTINE POUCH 98NCA11 | YOIK ABSWEDEN |
| 12/29/2025 | SNUS 98CCA06 | NICOTOBACCOPOLAND |
| 12/29/2025 | SNUS 98CCA06 | NICOTOBACCOPOLAND |
| 12/29/2025 | SNUS 98CCA06 | VIKA SVENSSON GOTHENBURGSWEDEN |
| 12/29/2025 | SNUS 98CCA06 | VIKA SVENSSON GOTHENBURGSWEDEN |
Frequently Asked Questions
What is FDA violation code 3843?
3843 is an FDA violation code that indicates: "This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be misbranded under section 903(a)(6) of the FD&C Act in that a notice or other information respecting it was not provided as required by section 905(j).". This violation is based on 801(a)(3);903(a)(6);MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3843?
According to FDA Import Refusal data, there have been 7103 import refusals issued for violation code 3843, affecting 366 unique firms.
When was the most recent refusal for violation 3843?
The most recent import refusal for violation 3843 was on December 31, 2025.
What products are commonly refused for violation 3843?
Products commonly refused under violation 3843 include: NICOTINE POUCH, NICOTINE DELIVERY PRODUCT, NEC. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3843?
Violation code 3843 is based on 801(a)(3);903(a)(6);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.