Violation Code: 3540
FDA Violation
Charge Code: NO EXP DAT
Violation Details
- Violation Code (ASC ID)
- 3540
- Charge Code
- NO EXP DAT
- Description
- The article appears to be a dietary supplement and lacks an expiration date and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practices. regulations, including regulations requiring, when necessary, expiration date labeling.
- Legal Section
- 402(g), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Inhairit Natural Solutions | Delta, CANADA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 7/5/2012 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FYE99 |
Frequently Asked Questions
What is FDA violation code 3540?
3540 is an FDA violation code that indicates: "The article appears to be a dietary supplement and lacks an expiration date and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practices. regulations, including regulations requiring, when necessary, expiration date labeling.". This violation is based on 402(g), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3540?
According to FDA Import Refusal data, there have been 1 import refusals issued for violation code 3540, affecting 1 unique firms.
When was the most recent refusal for violation 3540?
The most recent import refusal for violation 3540 was on July 5, 2012.
What products are commonly refused for violation 3540?
Products commonly refused under violation 3540 include: HERBALS & BOTANICALS (NOT TEAS), N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3540?
Violation code 3540 is based on 402(g), 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.