Violation Code: 3875
FDA Violation
Charge Code: 708REIMPRT
Violation Details
- Violation Code (ASC ID)
- 3875
- Charge Code
- 708REIMPRT
- Description
- The article has been determined to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
- Legal Section
- 801(d)(1),(2); IMPORTATION RESTRICTED
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Sanofi-Aventis US LLC | Saint Louis, UNITED STA | 6 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/2/2016 | ANALGESIC, N.E.C. 60LBK99 | Sanofi-Aventis US LLCUNITED STA |
| 12/2/2016 | ANALGESIC, N.E.C. 60LBK99 | Sanofi-Aventis US LLCUNITED STA |
| 12/2/2016 | ANALGESIC, N.E.C. 60LBK99 | Sanofi-Aventis US LLCUNITED STA |
| 12/2/2016 | ANALGESIC, N.E.C. 60LBK99 | Sanofi-Aventis US LLCUNITED STA |
| 12/2/2016 | ANALGESIC, N.E.C. 60LBK99 | Sanofi-Aventis US LLCUNITED STA |
| 12/2/2016 | ANALGESIC, N.E.C. 60LBK99 | Sanofi-Aventis US LLCUNITED STA |
Related Violations
Other violations under the same legal section: 801(d)(1),(2); IMPORTATION RESTRICTED
Frequently Asked Questions
What is FDA violation code 3875?
3875 is an FDA violation code that indicates: "The article has been determined to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.". This violation is based on 801(d)(1),(2); IMPORTATION RESTRICTED of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3875?
According to FDA Import Refusal data, there have been 6 import refusals issued for violation code 3875, affecting 1 unique firms.
When was the most recent refusal for violation 3875?
The most recent import refusal for violation 3875 was on December 2, 2016.
What products are commonly refused for violation 3875?
Products commonly refused under violation 3875 include: ANALGESIC, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3875?
Violation code 3875 is based on 801(d)(1),(2); IMPORTATION RESTRICTED 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.