Violation Code: 72
FDA Violation
Charge Code: NEW VET DR
Violation Details
- Violation Code (ASC ID)
- 72
- Charge Code
- NEW VET DR
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
- Legal Section
- 501(a)(5), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Omega Alpha Pharmaceuticals | Scarborough, CANADA | 151 |
| 2 | Mineral Medix Solutions Inc. | Richmond Hill, CANADA | 87 |
| 3 | Hebei Meiwei Chinese Medicinal Herbs Co., LTD | Anguo City, CHINA | 69 |
| 4 | Merial | Lyon, FRANCE | 52 |
| 5 | Easy Motion Horse Products Inc. | Grassie, CANADA | 49 |
| 6 | Medichin N.V. | Hasselt, BELGIUM | 47 |
| 7 | Shantou Olive Pharmaceutical Co.,Ltd | Shantou, CHINA | 46 |
| 8 | Laboratorios Tornel, S.A. | Naucalpan, MEXICO | 39 |
| 9 | Natures Formulae Health Products Ltd. | Kelowna, CANADA | 34 |
| 10 | Nutri Science Ltd | Waterford, IRELAND | 30 |
| 11 | Azmira Holistic Animal Care | Tucson, UNITED STA | 26 |
| 12 | Omega Alpha Pharmaceuticals | Scarborough, CANADA | 25 |
| 13 | Belgica De Weerd, B.V. | Breda, NETHERLAND | 20 |
| 14 | Pharma Belgica De Weerd | Breda, NETHERLAND | 20 |
| 15 | Laboratorios Ordonez Sa De Cv | Mexicomexico, MEXICO | 18 |
| 16 | Pet-Tek Distribution | Leduc, CANADA | 17 |
| 17 | Biologic Nutritional Research In | Surrey, CANADA | 16 |
| 18 | Innovacyn Inc. | Rialto, UNITED STA | 16 |
| 19 | Ardena U.S. LLC | Somerset, UNITED STA | 15 |
| 20 | Vet Products Online | Estcourt, SOUTH AFRI | 13 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/10/2025 | SAROLANER (ANTIPARASITIC) 60ZOA34 | Zoetis Belgium S.A.BELGIUM |
| 12/10/2025 | PYRANTEL PAMOATE (ANTIPARASITIC) 60ZRA32 | Zoetis Belgium S.A.BELGIUM |
| 12/2/2025 | IVERMECTIN CATEGORY II, TYPE A MEDICATED ARTICLE 67B14 | LABORATORIES ZOO DECNO SASCOLOMBIA |
| 12/1/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VIY99 | |
| 12/1/2025 | IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) 62LOO47 | HK YU TING TECHNOLOGY COHONG KONG |
| 11/14/2025 | FLUTICASONE PROPIONATE (BRONCHODILATOR) 63BCQ25 | GLAXOSMITHKLINECANADA |
| 11/14/2025 | INSULIN GLARGINE 58HCP09 | ELI LILLY CANADA INCCANADA |
| 11/10/2025 | REPLENISHER N.E.C. 65RPR99 | MPA VETERINARYSPAIN |
| 11/10/2025 | ALBENDAZOLE (ANTHELMINTIC) 60WPR01 | INOVETFRANCE |
| 11/10/2025 | ANTIPARASITIC, N.E.C. 60ZPL99 | INOVETFRANCE |
| 11/10/2025 | ANTI-MICROBIAL N.E.C. 62HPA99 | LELY PHARMA BVNETHERLAND |
| 11/10/2025 | CARNIDAZOLE (ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL) 62LPA01 | LELY PHARMA BVNETHERLAND |
| 11/10/2025 | RONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) 62LPA08 | LELY PHARMA BVNETHERLAND |
| 11/10/2025 | IVERMECTIN AND COMBINATIONS (ANTIPARASITIC) 60ZPL15 | Produlab PharmaNETHERLAND |
| 11/10/2025 | MENTHOL (ANTI-PRURITIC) 62MPQ08 | PRONAFIT BVNETHERLAND |
Related Violations
Other violations under the same legal section: 501(a)(5), 801(a)(3); ADULTERATION
Frequently Asked Questions
What is FDA violation code 72?
72 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.". 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 72?
According to FDA Import Refusal data, there have been 2546 import refusals issued for violation code 72, affecting 1008 unique firms.
When was the most recent refusal for violation 72?
The most recent import refusal for violation 72 was on December 10, 2025.
What products are commonly refused for violation 72?
Products commonly refused under violation 72 include: SAROLANER (ANTIPARASITIC), PYRANTEL PAMOATE (ANTIPARASITIC), IVERMECTIN CATEGORY II, TYPE A MEDICATED ARTICLE, MISCELLANEOUS PATENT MEDICINES, ETC., IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 72?
Violation code 72 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.