Violation Code: 3801
FDA Violation
Charge Code: FALSERXLBL
Violation Details
- Violation Code (ASC ID)
- 3801
- Charge Code
- FALSERXLBL
- Description
- The article is subject to refusal of admission pursuant section 801(a)(3) of the FD&C Act in that it appears to be misbranded as defined in section 503(b)(4)(B) of the FD&C Act. The labeling falsely bears the symbol "RX Only".
- Legal Section
- 503(b)(4)(B), 801(a)(3)
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Skin Farm | Gimpo, SOUTH KORE | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 4/23/2021 | ETHYL ALCOHOL (ANTI-MICROBIAL) 62HBL05 | Skin FarmSOUTH KORE |
Frequently Asked Questions
What is FDA violation code 3801?
3801 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant section 801(a)(3) of the FD&C Act in that it appears to be misbranded as defined in section 503(b)(4)(B) of the FD&C Act. The labeling falsely bears the symbol "RX Only".". This violation is based on 503(b)(4)(B), 801(a)(3) of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3801?
According to FDA Import Refusal data, there have been 1 import refusals issued for violation code 3801, affecting 1 unique firms.
When was the most recent refusal for violation 3801?
The most recent import refusal for violation 3801 was on April 23, 2021.
What products are commonly refused for violation 3801?
Products commonly refused under violation 3801 include: ETHYL ALCOHOL (ANTI-MICROBIAL). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3801?
Violation code 3801 is based on 503(b)(4)(B), 801(a)(3) 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.