Violation Code: 3580
FDA Violation
Charge Code: TP VIOL911
Violation Details
- Violation Code (ASC ID)
- 3580
- Charge Code
- TP VIOL911
- 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 appears to be in violation of section 911.
- Legal Section
- 902(8); 801(a)(3), Adulteration
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Dong Guan Best of Best Technologies Co., Ltd | Dongguan City, CHINA | 26 |
| 2 | Skruf Snus Ab | Stockholm, SWEDEN | 11 |
| 3 | Japan Tobacco in.c | Minato, JAPAN | 9 |
| 4 | Reemtsma International Gmbh | Hamburg, GERMANY | 9 |
| 5 | ANOTHER SNUS FACTORY STOCKHOLM AB | Stockholm, SWEDEN | 5 |
| 6 | Imp Tob | Nottingham, UNITED KIN | 5 |
| 7 | Filtra Tips Sarl | Zalka, LEBANON | 5 |
| 8 | Beijing Shiqiao Bio-pharmaceutical Co., LTD | Beijing, CHINA | 3 |
| 9 | Tonovex S.A. | Montevideo, URUGUAY | 2 |
| 10 | Pt Tresindo Asia Prima | Jakarta, INDONESIA | 2 |
| 11 | SHENZHEN HONGYAO TRADE CO., LTD. | Shenzhen, CHINA | 2 |
| 12 | Kt & G Corporation | 100 Pyungchon-Dong Taedeog-Ku T, SOUTH KORE | 1 |
| 13 | LCL DIS TICARET LIMITED SIRKETI | Osmangazi, TURKEY | 1 |
| 14 | Lns Dhanraj Tobacco Export | Achanakpur, INDIA | 1 |
| 15 | Make Webo Ab | Lidkoping, SWEDEN | 1 |
| 16 | Makro Logistics | Doral, UNITED STA | 1 |
| 17 | M/S Global Lotus | Gurgaon, INDIA | 1 |
| 18 | Otpima Tobacco | Timberlake, UNITED STA | 1 |
| 19 | Procesadora Nacional Cigarrillera Sa( Pronalci Sa) | Bucaramanga, COLOMBIA | 1 |
| 20 | ROBUST VENTURES LTD | London, UNITED KIN | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 6/25/2025 | ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC 98LCA99 | |
| 6/25/2025 | ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC 98LCA99 | |
| 6/6/2025 | E-CIGARETTE 98LAA01 | |
| 3/26/2025 | SNUS 98CCA06 | |
| 3/26/2025 | SNUS 98CCA06 | |
| 3/26/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | |
| 3/26/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | |
| 3/26/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | |
| 3/14/2025 | E-CIGARETTE 98LCA01 | |
| 3/14/2025 | E-CIGARETTE 98LCA01 | |
| 3/14/2025 | E-CIGARETTE 98LCA01 | |
| 3/14/2025 | E-CIGARETTE 98LCA01 | |
| 3/14/2025 | E-CIGARETTE 98LCA01 | |
| 3/14/2025 | E-CIGARETTE 98LCA01 | |
| 3/14/2025 | E-CIGARETTE 98LCA01 |
Frequently Asked Questions
What is FDA violation code 3580?
3580 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 appears to be in violation of section 911.". This violation is based on 902(8); 801(a)(3), Adulteration of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3580?
According to FDA Import Refusal data, there have been 102 import refusals issued for violation code 3580, affecting 34 unique firms.
When was the most recent refusal for violation 3580?
The most recent import refusal for violation 3580 was on June 25, 2025.
What products are commonly refused for violation 3580?
Products commonly refused under violation 3580 include: ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC, E-CIGARETTE, SNUS. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3580?
Violation code 3580 is based on 902(8); 801(a)(3), Adulteration 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.