Violation Code: 3879
FDA Violation
Charge Code: 708UDECAPI
Violation Details
- Violation Code (ASC ID)
- 3879
- Charge Code
- 708UDECAPI
- Description
- The article has been determined to contain an API that is undeclared on the label or accompanying labeling.
- Legal Section
- 502(a), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | HAN ITHALAT IHRACAT VE DANISMANLIK LTD STI | Pendik, TURKEY | 4 |
| 2 | EXPO CONNECT SDN BHD | Seri Kembangan, MALAYSIA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 5/21/2019 | TADALAFIL 66SCY51 | EXPO CONNECT SDN BHDMALAYSIA |
| 1/29/2019 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VAY99 | |
| 12/17/2018 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VAY99 | |
| 12/17/2018 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCS99 | |
| 12/17/2018 | SILDENAFIL CITRATE (REGULATOR) 65PCY02 |
Related Violations
Other violations under the same legal section: 502(a), 801(a)(3); MISBRANDING
Frequently Asked Questions
What is FDA violation code 3879?
3879 is an FDA violation code that indicates: "The article has been determined to contain an API that is undeclared on the label or accompanying labeling.". This violation is based on 502(a), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3879?
According to FDA Import Refusal data, there have been 5 import refusals issued for violation code 3879, affecting 2 unique firms.
When was the most recent refusal for violation 3879?
The most recent import refusal for violation 3879 was on May 21, 2019.
What products are commonly refused for violation 3879?
Products commonly refused under violation 3879 include: TADALAFIL, MISCELLANEOUS PATENT MEDICINES, ETC., SILDENAFIL CITRATE (REGULATOR). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3879?
Violation code 3879 is based on 502(a), 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.