Violation Code: 3867
FDA Violation
Charge Code: 708NORX
Violation Details
- Violation Code (ASC ID)
- 3867
- Charge Code
- 708NORX
- Description
- The article has been determined to be a a prescription drug without a prescription drug legend.
- Legal Section
- 502(a) & (f)(1), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | NP GANDOUR | Abidjan, IVORY COAS | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 9/4/2017 | SALICYLIC ACID (KERATOLYTIC) 64XBJ06 | NP GANDOURIVORY COAS |
Related Violations
Other violations under the same legal section: 502(a) & (f)(1), 801(a)(3); MISBRANDING
Frequently Asked Questions
What is FDA violation code 3867?
3867 is an FDA violation code that indicates: "The article has been determined to be a a prescription drug without a prescription drug legend.". This violation is based on 502(a) & (f)(1), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3867?
According to FDA Import Refusal data, there have been 1 import refusals issued for violation code 3867, affecting 1 unique firms.
When was the most recent refusal for violation 3867?
The most recent import refusal for violation 3867 was on September 4, 2017.
What products are commonly refused for violation 3867?
Products commonly refused under violation 3867 include: SALICYLIC ACID (KERATOLYTIC). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3867?
Violation code 3867 is based on 502(a) & (f)(1), 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.