Violation Code: 3891
FDA Violation
Charge Code: TPADULT1
Violation Details
- Violation Code (ASC ID)
- 3891
- Charge Code
- TPADULT1
- 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 adulterated under section 902(1) because it consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poisonous or added deleterious substance that may render the product injurious to health.
- Legal Section
- 902(1);801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | GRAND RIVER ENTERPRISES SIX NATI | Ohsweken, CANADA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 5/27/2020 | CIGARETTES 98BAA01 |
Frequently Asked Questions
What is FDA violation code 3891?
3891 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 adulterated under section 902(1) because it consists in whole or in part of any filthy, putrid, or decomposed substance, or is otherwise contaminated by any added poisonous or added deleterious substance that may render the product injurious to health.". This violation is based on 902(1);801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3891?
According to FDA Import Refusal data, there have been 1 import refusals issued for violation code 3891, affecting 1 unique firms.
When was the most recent refusal for violation 3891?
The most recent import refusal for violation 3891 was on May 27, 2020.
What products are commonly refused for violation 3891?
Products commonly refused under violation 3891 include: CIGARETTES. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3891?
Violation code 3891 is based on 902(1);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.