Violation Code: 3868
FDA Violation
Charge Code: 708VETLGND
Violation Details
- Violation Code (ASC ID)
- 3868
- Charge Code
- 708VETLGND
- Description
- The article has been determined to be a veterinary drug without the "Caution" statement as required by Section 503(f)(4).
- Legal Section
- 502(a) & (f)(1), 801(a)(3); MISBRANDING
Related Violations
Other violations under the same legal section: 502(a) & (f)(1), 801(a)(3); MISBRANDING
Frequently Asked Questions
What is FDA violation code 3868?
3868 is an FDA violation code that indicates: "The article has been determined to be a veterinary drug without the "Caution" statement as required by Section 503(f)(4).". This violation is based on 502(a) & (f)(1), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3868?
According to FDA Import Refusal data, there have been 0 import refusals issued for violation code 3868, affecting 0 unique firms.
When was the most recent refusal for violation 3868?
There is no recent refusal data available for violation 3868.
What products are commonly refused for violation 3868?
Various imported products may be refused under violation 3868 when they do not meet FDA requirements.
What is the legal basis for FDA violation code 3868?
Violation code 3868 is based on 502(a) & (f)(1), 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.