Violation Code: 3901
FDA Violation
Charge Code: VET DR LBL
Violation Details
- Violation Code (ASC ID)
- 3901
- Charge Code
- VET DR LBL
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it appears to be misbranded within the meaning of Section 502(w) of the FD&C Act in that it appears to be a new animal drug ?
- Legal Section
- 502(w), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | pK Chemicals A/S | Koge, DENMARK | 1 |
| 2 | LABORATORIOS MICROSULES URUGUAY | Canelones, URUGUAY | 1 |
| 3 | VET UK LTD | Ripon, UNITED KIN | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 10/27/2025 | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. 66YDY99 | VET UK LTDUNITED KIN |
| 6/21/2023 | ANIMAL FEEDS, N.E.C. 70YY99 | |
| 11/15/2021 | DEXTRAN 40 (PLASMA VOLUME EXTENDER) 65HSZ01 | pK Chemicals A/SDENMARK |
Frequently Asked Questions
What is FDA violation code 3901?
3901 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it appears to be misbranded within the meaning of Section 502(w) of the FD&C Act in that it appears to be a new animal drug ?". This violation is based on 502(w), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3901?
According to FDA Import Refusal data, there have been 3 import refusals issued for violation code 3901, affecting 3 unique firms.
When was the most recent refusal for violation 3901?
The most recent import refusal for violation 3901 was on October 27, 2025.
What products are commonly refused for violation 3901?
Products commonly refused under violation 3901 include: EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C., ANIMAL FEEDS, N.E.C., DEXTRAN 40 (PLASMA VOLUME EXTENDER). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3901?
Violation code 3901 is based on 502(w), 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.