Violation Code: 3882
FDA Violation
Charge Code: 708NORX
Violation Details
- Violation Code (ASC ID)
- 3882
- Charge Code
- 708NORX
- Description
- The article has been determined to be a prescription drug but does not include the symbol "Rx only" on its label.
- Legal Section
- 503(b)(4), 801(a)(3); MISBRANDING
Frequently Asked Questions
What is FDA violation code 3882?
3882 is an FDA violation code that indicates: "The article has been determined to be a prescription drug but does not include the symbol "Rx only" on its label.". This violation is based on 503(b)(4), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3882?
According to FDA Import Refusal data, there have been 0 import refusals issued for violation code 3882, affecting 0 unique firms.
When was the most recent refusal for violation 3882?
There is no recent refusal data available for violation 3882.
What products are commonly refused for violation 3882?
Various imported products may be refused under violation 3882 when they do not meet FDA requirements.
What is the legal basis for FDA violation code 3882?
Violation code 3882 is based on 503(b)(4), 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.