Violation Code: 343
FDA Violation
Charge Code: VET LEGEND
Violation Details
- Violation Code (ASC ID)
- 343
- Charge Code
- VET LEGEND
- Description
- The article appears to be a veterinary drug without the "Caution" statement as required by Section 503(f)(4).
- Legal Section
- 502(a) & (f)(1), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Abbeyvet Exp | Leeds, UNITED KIN | 6 |
| 2 | Vetafarm Pty Ltd | Wagga Wagga, AUSTRALIA | 5 |
| 3 | Lab De Dermocosmetique Animale | Za Le Causse, FRANCE | 3 |
| 4 | Apotheek Jorissen Nv | Hoeselt, BELGIUM | 2 |
| 5 | Vet Products | Mitchelton, AUSTRALIA | 2 |
| 6 | NIKITIN YURIY | Kiev, UKRAINE | 2 |
| 7 | Bachem AG | Bubendorf, SWITZERLAN | 1 |
| 8 | Freed Jacob | Winnipeg, CANADA | 1 |
| 9 | Dioptrix | L Union, FRANCE | 1 |
| 10 | Colcott | Bomen, AUSTRALIA | 1 |
| 11 | Wiwi Ltd | London, UNITED KIN | 1 |
| 12 | SV Labs Toronto Corporation | Brampton, CANADA | 1 |
| 13 | Sterling Pharmacy Ltd | West Didsbury, UNITED KIN | 1 |
| 14 | Sinochem Pharmaceutical Co., Ltd. | Nanjing, CHINA | 1 |
| 15 | Access Animal Health Agencies Pty Ltd | Roseville, AUSTRALIA | 1 |
| 16 | Bayer Australia Ltd. | Pymble, AUSTRALIA | 1 |
| 17 | Boehringer Ingelheim Animal Health France | Toulouse, FRANCE | 1 |
| 18 | Novartis Animal Health Australia | Wentworthville, AUSTRALIA | 1 |
| 19 | Shanghai East Asia Chemical Co Ltd | Putuo, CHINA | 1 |
| 20 | M Shaw | Mitchelton, AUSTRALIA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 6/19/2017 | OTHER ANIMAL, N.E.C. WOUND DRESSING 68KYY99 | NIKITIN YURIYUKRAINE |
| 6/19/2017 | OTHER ANIMAL, N.E.C. DEVICE/DIAG PROD FOR ANIMAL 68XYY99 | NIKITIN YURIYUKRAINE |
| 10/27/2014 | DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) 62GQO90 | Sterling Pharmacy LtdUNITED KIN |
| 10/1/2014 | ANTI-ECZEMATIC N.E.C. 61SPL99 | |
| 10/1/2014 | ANTI-ECZEMATIC N.E.C. 61SPL99 | |
| 10/1/2014 | ANTI-ECZEMATIC N.E.C. 61SPL99 | |
| 9/18/2014 | PRAZIQUANTEL (ANTI-SCHISTOSOMAL) 62ROR11 | |
| 4/2/2014 | IN-VITRO DIAG PRODUCTS, N.E.C. 57VL99 | Bachem AGSWITZERLAN |
| 12/17/2013 | MELOXICAM (ANTI-INFLAMMATORY, PART II) 62YPK07 | Wiwi LtdUNITED KIN |
| 9/23/2013 | OTHER PET FOOD, N.E.C. 72EYY99 | ColcottAUSTRALIA |
| 5/17/2011 | ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL, N.E.C. 62LQR99 | Vetafarm Pty LtdAUSTRALIA |
| 5/17/2011 | ANTI-BACTERIAL, N.E.C. 61HPY99 | Vetafarm Pty LtdAUSTRALIA |
| 5/17/2011 | ANTI-BACTERIAL, N.E.C. 61HPY99 | Vetafarm Pty LtdAUSTRALIA |
| 5/17/2011 | ANTI-BACTERIAL, N.E.C. 61HPY99 | Vetafarm Pty LtdAUSTRALIA |
| 5/17/2011 | RONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) 62LJR08 | Vetafarm Pty LtdAUSTRALIA |
Related Violations
Other violations under the same legal section: 502(a) & (f)(1), 801(a)(3); MISBRANDING
Frequently Asked Questions
What is FDA violation code 343?
343 is an FDA violation code that indicates: "The article appears to be a veterinary drug without the "Caution" statement as required by Section 503(f)(4).". This violation is based on 502(a) & (f)(1), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 343?
According to FDA Import Refusal data, there have been 34 import refusals issued for violation code 343, affecting 20 unique firms.
When was the most recent refusal for violation 343?
The most recent import refusal for violation 343 was on June 19, 2017.
What products are commonly refused for violation 343?
Products commonly refused under violation 343 include: OTHER ANIMAL, N.E.C. WOUND DRESSING, OTHER ANIMAL, N.E.C. DEVICE/DIAG PROD FOR ANIMAL, DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY), ANTI-ECZEMATIC N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 343?
Violation code 343 is based on 502(a) & (f)(1), 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.