Violation Code: 3850
FDA Violation
Charge Code: TPNOHLDOCS
Violation Details
- Violation Code (ASC ID)
- 3850
- Charge Code
- TPNOHLDOCS
- 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 documents related to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents(including smoke constituents), ingredients, components, and additives were not submitted as required under section 904(a)(4).
- 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 3850?
3850 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 documents related to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents(including smoke constituents), ingredients, components, and additives were not submitted as required under section 904(a)(4).". 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 3850?
According to FDA Import Refusal data, there have been 0 import refusals issued for violation code 3850, affecting 0 unique firms.
When was the most recent refusal for violation 3850?
There is no recent refusal data available for violation 3850.
What products are commonly refused for violation 3850?
Various imported products may be refused under violation 3850 when they do not meet FDA requirements.
What is the legal basis for FDA violation code 3850?
Violation code 3850 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.