Violation Code: 3866
FDA Violation
Charge Code: 708NEWANIM
Violation Details
- Violation Code (ASC ID)
- 3866
- Charge Code
- 708NEWANIM
- Description
- The article has been determined to be a new animal drug without an approved new animal drug application.
- Legal Section
- 501(a)(5), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | EC LABS SA | Cordoba, ARGENTINA | 2 |
| 2 | BIOPHARMEX A DE CV | Ciudad, MEXICO | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 10/16/2024 | HOMEOPATHIC GASTROINTESTINAL 66XPL05 | BIOPHARMEX A DE CVMEXICO |
| 5/19/2023 | MENTHOL (ANTI-PRURITIC) 62MPJ08 | EC LABS SAARGENTINA |
| 5/19/2023 | ARNICA (HERBAL & BOTANICALS, NOT TEAS) 54FNJ32 | EC LABS SAARGENTINA |
Related Violations
Other violations under the same legal section: 501(a)(5), 801(a)(3); ADULTERATION
Frequently Asked Questions
What is FDA violation code 3866?
3866 is an FDA violation code that indicates: "The article has been determined to be a new animal drug without an approved new animal drug application.". This violation is based on 501(a)(5), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3866?
According to FDA Import Refusal data, there have been 3 import refusals issued for violation code 3866, affecting 2 unique firms.
When was the most recent refusal for violation 3866?
The most recent import refusal for violation 3866 was on October 16, 2024.
What products are commonly refused for violation 3866?
Products commonly refused under violation 3866 include: HOMEOPATHIC GASTROINTESTINAL, MENTHOL (ANTI-PRURITIC), ARNICA (HERBAL & BOTANICALS, NOT TEAS). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3866?
Violation code 3866 is based on 501(a)(5), 801(a)(3); ADULTERATION 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.