Violation Code: 3849
FDA Violation
Charge Code: TP NO HPHC
Violation Details
- Violation Code (ASC ID)
- 3849
- Charge Code
- TP NO HPHC
- 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 listing of constituents, including smoke constituents, identified as harmful or potentially harmful to health in each tobacco product was not submitted as required under section 904(a)(3).
- 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 3849?
3849 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 listing of constituents, including smoke constituents, identified as harmful or potentially harmful to health in each tobacco product was not submitted as required under section 904(a)(3).". 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 3849?
According to FDA Import Refusal data, there have been 0 import refusals issued for violation code 3849, affecting 0 unique firms.
When was the most recent refusal for violation 3849?
There is no recent refusal data available for violation 3849.
What products are commonly refused for violation 3849?
Various imported products may be refused under violation 3849 when they do not meet FDA requirements.
What is the legal basis for FDA violation code 3849?
Violation code 3849 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.