Violation Code: 3870
FDA Violation
Charge Code: 708NOENGL
Violation Details
- Violation Code (ASC ID)
- 3870
- Charge Code
- 708NOENGL
- Description
- Required label or labeling has been determined to not be in English in violation of 21 C.F.R. 201.15(c)(1).
- Legal Section
- 502(c); 801(a)(3) ;MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | INSTITUT KATHAROS | Aix En Provence, FRANCE | 2 |
| 2 | Kan Productions Sarl | Melegnano, ITALY | 1 |
| 3 | Inovatyvus Sprendimai UAB | Kovno, LITHUANIA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 8/12/2019 | DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) 62UBY11 | Inovatyvus Sprendimai UABLITHUANIA |
| 7/18/2019 | SALICYLIC ACID (KERATOLYTIC) 64XBY06 | Kan Productions SarlITALY |
| 7/10/2018 | DISINFECTANT N.E.C. 64AAL99 | INSTITUT KATHAROSFRANCE |
| 7/10/2018 | DISINFECTANT N.E.C. 64AAL99 | INSTITUT KATHAROSFRANCE |
Related Violations
Other violations under the same legal section: 502(c); 801(a)(3) ;MISBRANDING
| Code | Charge Code | Cases |
|---|---|---|
| 472 | NO ENGLISH | 3622 |
Frequently Asked Questions
What is FDA violation code 3870?
3870 is an FDA violation code that indicates: "Required label or labeling has been determined to not be in English in violation of 21 C.F.R. 201.15(c)(1).". This violation is based on 502(c); 801(a)(3) ;MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3870?
According to FDA Import Refusal data, there have been 4 import refusals issued for violation code 3870, affecting 3 unique firms.
When was the most recent refusal for violation 3870?
The most recent import refusal for violation 3870 was on August 12, 2019.
What products are commonly refused for violation 3870?
Products commonly refused under violation 3870 include: DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD), SALICYLIC ACID (KERATOLYTIC), DISINFECTANT N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3870?
Violation code 3870 is based on 502(c); 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.