Violation Code: 3848
FDA Violation
Charge Code: TP NO ING
Violation Details
- Violation Code (ASC ID)
- 3848
- Charge Code
- TP NO ING
- 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)(10)(A) in that a list of all ingredients, including tobacco, substances, compounds, and additives that are added by the manufacturer to the tobacco, paper, filter, or part of each tobacco product by brand and by quantity in each brand and sub-brand was not submitted as required under section 904(a)(1).
- Legal Section
- 903(a)(10)(A); 801(a)(3) MISBRANDING
Related Violations
Other violations under the same legal section: 903(a)(10)(A); 801(a)(3) MISBRANDING
Frequently Asked Questions
What is FDA violation code 3848?
3848 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)(10)(A) in that a list of all ingredients, including tobacco, substances, compounds, and additives that are added by the manufacturer to the tobacco, paper, filter, or part of each tobacco product by brand and by quantity in each brand and sub-brand was not submitted as required under section 904(a)(1).". This violation is based on 903(a)(10)(A); 801(a)(3) MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3848?
According to FDA Import Refusal data, there have been 0 import refusals issued for violation code 3848, affecting 0 unique firms.
When was the most recent refusal for violation 3848?
There is no recent refusal data available for violation 3848.
What products are commonly refused for violation 3848?
Various imported products may be refused under violation 3848 when they do not meet FDA requirements.
What is the legal basis for FDA violation code 3848?
Violation code 3848 is based on 903(a)(10)(A); 801(a)(3) 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.