Violation Code: 3858
FDA Violation
Charge Code: TPFDA4ALBL
Violation Details
- Violation Code (ASC ID)
- 3858
- Charge Code
- TPFDA4ALBL
- 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 misbranded under section 903(a)(1) in that the label or labeling is false or misleading because it conveys that the product is safe or less harmful by virtue of its regulation or inspection by the FDA.
- Legal Section
- 903(a)(1); 801(a)(3); 301(tt)(4)(A); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Dong Guan Best of Best Technologies Co., Ltd | Dongguan City, CHINA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 3/14/2025 | E-CIGARETTE 98LCA01 |
Frequently Asked Questions
What is FDA violation code 3858?
3858 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 misbranded under section 903(a)(1) in that the label or labeling is false or misleading because it conveys that the product is safe or less harmful by virtue of its regulation or inspection by the FDA.". This violation is based on 903(a)(1); 801(a)(3); 301(tt)(4)(A); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3858?
According to FDA Import Refusal data, there have been 1 import refusals issued for violation code 3858, affecting 1 unique firms.
When was the most recent refusal for violation 3858?
The most recent import refusal for violation 3858 was on March 14, 2025.
What products are commonly refused for violation 3858?
Products commonly refused under violation 3858 include: E-CIGARETTE. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3858?
Violation code 3858 is based on 903(a)(1); 801(a)(3); 301(tt)(4)(A); 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.