Violation Code: 2202
FDA Violation
Charge Code: INSAN BSE
Violation Details
- Violation Code (ASC ID)
- 2202
- Charge Code
- INSAN BSE
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health.
- Legal Section
- 402(a)(4), 801(a)(3); Adulteration
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | BCG Baden-Baden Cosmetics Group GmbH | Baden-Baden, GERMANY | 1 |
| 2 | Biobake Inc. | Woodbridge, CANADA | 1 |
| 3 | Mitsubishi Kagku Foods Corp | Tokyo, JAPAN | 1 |
| 4 | Neo Nutritionals Inc | Brantford, CANADA | 1 |
| 5 | Idbio | Saint-Hyacinthe, CANADA | 1 |
| 6 | Holusta Health Corp | Coquitlam, BAHAMAS | 1 |
| 7 | CURVES N SPICE | Mississauga, CANADA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/3/2025 | COLLAGEN (COSMETIC RAW MATERIAL) 53PL02 | CURVES N SPICECANADA |
| 6/7/2011 | DIETARY CONVENTIONAL FOODS, N.E.C. 41YYT99 | Neo Nutritionals IncCANADA |
| 1/16/2009 | PET DOG FOOD N.E.C. 72BGY99 | Biobake Inc.CANADA |
| 8/30/2004 | VITAMIN, N.E.C. 54AYY99 | Holusta Health CorpBAHAMAS |
| 3/3/2004 | BOVINE (COW, ETC.) (ANIMAL BY-PRODUCTS AND EXTRACTS) 54GYY01 | |
| 3/14/2003 | BOVINE (COW, ETC.) (ANIMAL BY-PRODUCTS AND EXTRACTS) 54G01 | IdbioCANADA |
| 4/3/2002 | COLLAGEN (COSMETIC RAW MATERIAL) 53PC02 |
Related Violations
Other violations under the same legal section: 402(a)(4), 801(a)(3); Adulteration
| Code | Charge Code | Cases |
|---|---|---|
| 2220 | INGRED FIL | 1 |
Frequently Asked Questions
What is FDA violation code 2202?
2202 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 have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health.". This violation is based on 402(a)(4), 801(a)(3); Adulteration of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 2202?
According to FDA Import Refusal data, there have been 7 import refusals issued for violation code 2202, affecting 7 unique firms.
When was the most recent refusal for violation 2202?
The most recent import refusal for violation 2202 was on December 3, 2025.
What products are commonly refused for violation 2202?
Products commonly refused under violation 2202 include: COLLAGEN (COSMETIC RAW MATERIAL), DIETARY CONVENTIONAL FOODS, N.E.C., PET DOG FOOD N.E.C., VITAMIN, N.E.C., BOVINE (COW, ETC.) (ANIMAL BY-PRODUCTS AND EXTRACTS). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 2202?
Violation code 2202 is based on 402(a)(4), 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.