Violation Code: 2201
FDA Violation
Charge Code: BSE FILTH
Violation Details
- Violation Code (ASC ID)
- 2201
- Charge Code
- BSE FILTH
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be unfit for food.
- Legal Section
- 402(a)(3), 801(a)(3); Adulteration
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Khang Health Products Ltd | Richmond Hill, CANADA | 7 |
| 2 | SHURGAIN NUTRECO | Saint-Hyacinthe, CANADA | 3 |
| 3 | Moulee Vallee Feed Inc | Richmond, CANADA | 3 |
| 4 | Feely Msp Co., Ltd | Seoul, SOUTH KORE | 1 |
| 5 | Centro El Horizonte Del Reencuentro Sc | Zapopan, MEXICO | 1 |
| 6 | POWERVEDIC NATURALS | Regina, CANADA | 1 |
| 7 | Sheng Chang Pharmaceutical Co., Ltd | Taipei, TAIWAN | 1 |
| 8 | Tibon-Veal Holdings Ltd. | Kiryat Malachi, ISRAEL | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 10/10/2025 | BOVINE (COW, ETC.) (ANIMAL BY-PRODUCTS AND EXTRACTS) 54GBR01 | POWERVEDIC NATURALSCANADA |
| 7/3/2019 | MONENSIN CATEGORY I, MEDICATED ANIMAL FEED 69AD34 | SHURGAIN NUTRECOCANADA |
| 7/3/2019 | MONENSIN CATEGORY I, MEDICATED ANIMAL FEED 69AD34 | SHURGAIN NUTRECOCANADA |
| 7/3/2019 | MONENSIN CATEGORY I, MEDICATED ANIMAL FEED 69AD34 | SHURGAIN NUTRECOCANADA |
| 1/18/2013 | PROTEIN N.E.C. 54CCK99 | |
| 4/14/2009 | CATTLE MIXED FEED RATION 70MY01 | Moulee Vallee Feed IncCANADA |
| 4/14/2009 | CATTLE MIXED FEED RATION 70MY01 | Moulee Vallee Feed IncCANADA |
| 4/14/2009 | POULTRY MIXED FEED RATION 70MY03 | Moulee Vallee Feed IncCANADA |
| 7/27/2007 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YEH99 | |
| 7/27/2007 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YEH99 | |
| 7/27/2007 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YEH99 | |
| 7/27/2007 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YEH99 | |
| 7/27/2007 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YEH99 | |
| 7/27/2007 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YEH99 | |
| 7/27/2007 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YEH99 |
Related Violations
Other violations under the same legal section: 402(a)(3), 801(a)(3); Adulteration
| Code | Charge Code | Cases |
|---|---|---|
| 2200 | DIET INGRE | 147 |
Frequently Asked Questions
What is FDA violation code 2201?
2201 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 unfit for food.". This violation is based on 402(a)(3), 801(a)(3); Adulteration of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 2201?
According to FDA Import Refusal data, there have been 18 import refusals issued for violation code 2201, affecting 8 unique firms.
When was the most recent refusal for violation 2201?
The most recent import refusal for violation 2201 was on October 10, 2025.
What products are commonly refused for violation 2201?
Products commonly refused under violation 2201 include: BOVINE (COW, ETC.) (ANIMAL BY-PRODUCTS AND EXTRACTS), MONENSIN CATEGORY I, MEDICATED ANIMAL FEED, PROTEIN N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 2201?
Violation code 2201 is based on 402(a)(3), 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.