Violation Code: 2840
FDA Violation
Charge Code: BSE DRUGS
Violation Details
- Violation Code (ASC ID)
- 2840
- Charge Code
- BSE DRUGS
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(1) 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
- 501(a)(2)(A), 801(a)(1); Adulteration
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Nutracos | Paris-L'Hopital, FRANCE | 4 |
| 2 | Nutra Med | Duncan, CANADA | 3 |
| 3 | A. Nelson & Co., Ltd. | London, UNITED KIN | 1 |
| 4 | Delta Pharma Inc. | Dorval, CANADA | 1 |
| 5 | Silhouette International | Altrincham, UNITED KIN | 1 |
| 6 | PRODUCTOS JUMAM EIRL | Brena, PERU | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/10/2025 | RELAXANT N.E.C. 65QBH99 | A. Nelson & Co., Ltd.UNITED KIN |
| 4/2/2014 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VBJ99 | Delta Pharma Inc.CANADA |
| 5/24/2007 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VBJ99 | |
| 10/21/2005 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VBJ99 | NutracosFRANCE |
| 10/21/2005 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VBJ99 | NutracosFRANCE |
| 9/28/2005 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VBJ99 | NutracosFRANCE |
| 9/28/2005 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VBJ99 | NutracosFRANCE |
| 7/11/2003 | OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C. 68YDR99 | Nutra MedCANADA |
| 7/11/2003 | HORSES ANIMAL DRUGS N.E.C. 68YDS02 | Nutra MedCANADA |
| 7/11/2003 | HORSES ANTI-INFECTIVE 68BBX02 | Nutra MedCANADA |
| 11/18/2002 | OTHER EYE MAKEUP PREPARATIONS, N.E.C. 53CF99 | Silhouette InternationalUNITED KIN |
Frequently Asked Questions
What is FDA violation code 2840?
2840 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(1) 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 501(a)(2)(A), 801(a)(1); Adulteration of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 2840?
According to FDA Import Refusal data, there have been 11 import refusals issued for violation code 2840, affecting 6 unique firms.
When was the most recent refusal for violation 2840?
The most recent import refusal for violation 2840 was on January 10, 2025.
What products are commonly refused for violation 2840?
Products commonly refused under violation 2840 include: RELAXANT N.E.C., MISCELLANEOUS PATENT MEDICINES, ETC.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 2840?
Violation code 2840 is based on 501(a)(2)(A), 801(a)(1); 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.