Violation Code: 3860
FDA Violation
Charge Code: TP USERFEE
Violation Details
- Violation Code (ASC ID)
- 3860
- Charge Code
- TP USERFEE
- Description
- This article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that the tobacco product appears to be adulterated under Section 902(4) because the importer of the tobacco product failed to pay a user fee assessed to such importer pursuant to Section 919 by the date specified in Section 919 or by the 30th day after final agency action on a resolution of any dispute as to the amount of the fee.
- Legal Section
- 902(4);801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | PLATAFORMA ARCOIRIS, S. A. | SANTIAGO, DOMINICAN | 14 |
| 2 | New Image Mexico, S.A. De C.V. | Tijuana, MEXICO | 5 |
| 3 | GRAND RIVER ENTERPRISES SIX NATI | Ohsweken, CANADA | 4 |
| 4 | Grand River Enterprises Six Nations Ltd | Oskweken, CANADA | 2 |
| 5 | EMIMAR, S.A. | Santiago, DOMINICAN | 1 |
| 6 | Skruf Snus Ab | Savsjo, SWEDEN | 1 |
| 7 | SILVERFOILTUBES INTL INC | Batangas, PHILIPPINE | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/24/2025 | NICOTINE DELIVERY PRODUCT, NEC 98NCA99 | Skruf Snus AbSWEDEN |
| 7/18/2023 | CIGAR 98GAA02 | PLATAFORMA ARCOIRIS, S. A.DOMINICAN |
| 8/26/2022 | ROLL-YOUR-OWN TOBACCO, LOOSE LEAF, LIGHT, MILD, OR LOW 98DCA05 | EMIMAR, S.A.DOMINICAN |
| 5/12/2022 | CIGAR 98GAA02 | PLATAFORMA ARCOIRIS, S. A.DOMINICAN |
| 5/4/2022 | CIGAR 98GAA02 | PLATAFORMA ARCOIRIS, S. A.DOMINICAN |
| 5/4/2022 | CIGAR 98GAA02 | PLATAFORMA ARCOIRIS, S. A.DOMINICAN |
| 5/4/2022 | CIGAR 98GAA02 | PLATAFORMA ARCOIRIS, S. A.DOMINICAN |
| 5/4/2022 | CIGAR 98GAA02 | PLATAFORMA ARCOIRIS, S. A.DOMINICAN |
| 4/26/2022 | CIGAR 98GAA02 | PLATAFORMA ARCOIRIS, S. A.DOMINICAN |
| 4/26/2022 | CIGAR 98GAA02 | PLATAFORMA ARCOIRIS, S. A.DOMINICAN |
| 4/14/2022 | CIGAR 98GAA02 | PLATAFORMA ARCOIRIS, S. A.DOMINICAN |
| 4/11/2022 | CIGAR 98GAA02 | PLATAFORMA ARCOIRIS, S. A.DOMINICAN |
| 4/11/2022 | CIGAR 98GAA02 | PLATAFORMA ARCOIRIS, S. A.DOMINICAN |
| 4/8/2022 | CIGAR 98GAA02 | PLATAFORMA ARCOIRIS, S. A.DOMINICAN |
| 4/8/2022 | CIGAR 98GAA02 | PLATAFORMA ARCOIRIS, S. A.DOMINICAN |
Frequently Asked Questions
What is FDA violation code 3860?
3860 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 in that the tobacco product appears to be adulterated under Section 902(4) because the importer of the tobacco product failed to pay a user fee assessed to such importer pursuant to Section 919 by the date specified in Section 919 or by the 30th day after final agency action on a resolution of any dispute as to the amount of the fee.". This violation is based on 902(4);801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3860?
According to FDA Import Refusal data, there have been 28 import refusals issued for violation code 3860, affecting 7 unique firms.
When was the most recent refusal for violation 3860?
The most recent import refusal for violation 3860 was on January 24, 2025.
What products are commonly refused for violation 3860?
Products commonly refused under violation 3860 include: NICOTINE DELIVERY PRODUCT, NEC, CIGAR, ROLL-YOUR-OWN TOBACCO, LOOSE LEAF, LIGHT, MILD, OR LOW. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3860?
Violation code 3860 is based on 902(4);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.