Violation Code: 3601
FDA Violation
Charge Code: IMITN DR
Violation Details
- Violation Code (ASC ID)
- 3601
- Charge Code
- IMITN DR
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be an imitation of another drug. The artice resembles:
- Legal Section
- 502(i) (2), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Maquiladora Gana, S.A. de C.V. | San Luis Potosi, MEXICO | 1 |
| 2 | Phyllis Co., Ltd. | Taipei, TAIWAN | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 7/22/2011 | ANTI-TUSSIVE/COLD N.E.C. 62UAY99 | |
| 1/18/2011 | SILDENAFIL CITRATE (REGULATOR) 65PCA02 | Phyllis Co., Ltd.TAIWAN |
Frequently Asked Questions
What is FDA violation code 3601?
3601 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be an imitation of another drug. The artice resembles: ". This violation is based on 502(i) (2), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3601?
According to FDA Import Refusal data, there have been 2 import refusals issued for violation code 3601, affecting 2 unique firms.
When was the most recent refusal for violation 3601?
The most recent import refusal for violation 3601 was on July 22, 2011.
What products are commonly refused for violation 3601?
Products commonly refused under violation 3601 include: ANTI-TUSSIVE/COLD N.E.C., SILDENAFIL CITRATE (REGULATOR). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3601?
Violation code 3601 is based on 502(i) (2), 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.