Violation Code: 3876
FDA Violation
Charge Code: GDUFA FEE
Violation Details
- Violation Code (ASC ID)
- 3876
- Charge Code
- GDUFA FEE
- Description
- The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(aa) of the Act. It appears the drug or active pharmaceutical ingredient was manufactured, prepared, propagated, compounded, or processed in a facility for which fees have not been paid as required in 21 U.S.C. Section 379j-42(a)(4), or it contains an active pharmaceutical ingredient that was manufactured, prepared, propagated, compounded, or processed in such a facility.
- Legal Section
- 502(aa), 801(a)(3);MISBRANDING
Frequently Asked Questions
What is FDA violation code 3876?
3876 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(aa) of the Act. It appears the drug or active pharmaceutical ingredient was manufactured, prepared, propagated, compounded, or processed in a facility for which fees have not been paid as required in 21 U.S.C. Section 379j-42(a)(4), or it contains an active pharmaceutical ingredient that was manufactured, prepared, propagated, compounded, or processed in such a facility.". This violation is based on 502(aa), 801(a)(3);MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3876?
According to FDA Import Refusal data, there have been 0 import refusals issued for violation code 3876, affecting 0 unique firms.
When was the most recent refusal for violation 3876?
There is no recent refusal data available for violation 3876.
What products are commonly refused for violation 3876?
Various imported products may be refused under violation 3876 when they do not meet FDA requirements.
What is the legal basis for FDA violation code 3876?
Violation code 3876 is based on 502(aa), 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.