Violation Code: 3880
FDA Violation
Charge Code: 708FALSE
Violation Details
- Violation Code (ASC ID)
- 3880
- Charge Code
- 708FALSE
- Description
- The labeling for this article is determined to be false or misleading
- Legal Section
- 502(a), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Laavo Clean, S.A. de C.V. | Ciudad Apodaca, MEXICO | 1 |
| 2 | ANINA INNOTHERAPEURICS PVT LTD | Thane, INDIA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 6/16/2022 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VDY99 | |
| 3/9/2022 | ANTI-MICROBIAL N.E.C. 62HAL99 |
Related Violations
Other violations under the same legal section: 502(a), 801(a)(3); MISBRANDING
Frequently Asked Questions
What is FDA violation code 3880?
3880 is an FDA violation code that indicates: "The labeling for this article is determined to be false or misleading". This violation is based on 502(a), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3880?
According to FDA Import Refusal data, there have been 2 import refusals issued for violation code 3880, affecting 2 unique firms.
When was the most recent refusal for violation 3880?
The most recent import refusal for violation 3880 was on June 16, 2022.
What products are commonly refused for violation 3880?
Products commonly refused under violation 3880 include: MISCELLANEOUS PATENT MEDICINES, ETC., ANTI-MICROBIAL N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3880?
Violation code 3880 is based on 502(a), 801(a)(3); MISBRANDING 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.