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 | 749 |
| 2 | Swedish Match Ab | Stockholm, SWEDEN | 441 |
| 3 | APRES NICOTINE AB | Vetlanda, SWEDEN | 360 |
| 4 | HABIT FACTORY IN SWEDEN AB | Arsta, SWEDEN | 254 |
| 5 | NGP TOBACCO APS | Norager, DENMARK | 224 |
| 6 | Skruf Snus Ab | Stockholm, SWEDEN | 223 |
| 7 | Luna Corporate | Suchy Las, POLAND | 200 |
| 8 | YOIK AB | Gemla, SWEDEN | 195 |
| 9 | GUANGDONG TOULANG INTERNATIONALLOGISTICS CO., LTD | Shenzhen, CHINA | 167 |
| 10 | Fiedler & Lundgren Ab | Malmo, SWEDEN | 154 |
| 11 | LIW INNOVATION AB | Hokerum, SWEDEN | 154 |
| 12 | CHAINPOP AB | Goteborg, SWEDEN | 147 |
| 13 | HELIX SWEDEN AB | Helsingborg, SWEDEN | 141 |
| 14 | CBI SRO | Teplice, CZECH REPU | 137 |
| 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 | 96 |
| 19 | MICROZERO AB | Goteborg, SWEDEN | 81 |
| 20 | Shenzhen Joecig Technology Co Ltd | Shenzhen, CHINA | 75 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/22/2026 | NICOTINE POUCH 98NCA11 | Skruf Snus AbSWEDEN |
| 1/22/2026 | NICOTINE POUCH 98NAA11 | PHILIP MORRIS ABSWEDEN |
| 1/22/2026 | NICOTINE POUCH 98NCA11 | LIW INNOVATION ABSWEDEN |
| 1/22/2026 | NICOTINE POUCH 98NBA11 | NGP TOBACCO APSDENMARK |
| 1/21/2026 | NICOTINE POUCH 98NCA11 | PHILIP MORRIS ABSWEDEN |
| 1/21/2026 | NICOTINE POUCH 98NCA11 | PHILIP MORRIS ABSWEDEN |
| 1/21/2026 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | ORDERUP SWEDEN ABSWEDEN |
| 1/21/2026 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | |
| 1/16/2026 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | PHILIP MORRIS ABSWEDEN |
| 1/16/2026 | NICOTINE POUCH 98NCA11 | Phillip Morris Products SASWITZERLAN |
| 1/16/2026 | NICOTINE POUCH 98NCA11 | RAA S ABSWEDEN |
| 1/15/2026 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | LIW INNOVATION ABSWEDEN |
| 1/14/2026 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | LIW INNOVATION ABSWEDEN |
| 1/14/2026 | NICOTINE POUCH 98NCA11 | PHILIP MORRIS ABSWEDEN |
| 1/14/2026 | NICOTINE POUCH 98NCA11 | PHILIP MORRIS ABSWEDEN |
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 7281 import refusals issued for violation code 3843, affecting 370 unique firms.
When was the most recent refusal for violation 3843?
The most recent import refusal for violation 3843 was on January 22, 2026.
What products are commonly refused for violation 3843?
Products commonly refused under violation 3843 include: NICOTINE POUCH. 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.