Violation Code: 3884
FDA Violation
Charge Code: ADDDRUGBIO
Violation Details
- Violation Code (ASC ID)
- 3884
- Charge Code
- ADDDRUGBIO
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a food to which has been added either a drug approved under section 505, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public; and it appears that none of the exceptions listed in 301(ll)(1)-(4) applies.
- Legal Section
- 801(a)(3);301(ll); PROHIBITED ACT
Related Violations
Other violations under the same legal section: 801(a)(3);301(ll); PROHIBITED ACT
| Code | Charge Code | Cases |
|---|---|---|
| 3887 | ADDDRUGBIO | 23 |
Frequently Asked Questions
What is FDA violation code 3884?
3884 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 a food to which has been added either a drug approved under section 505, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public; and it appears that none of the exceptions listed in 301(ll)(1)-(4) applies.". This violation is based on 801(a)(3);301(ll); PROHIBITED ACT of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3884?
According to FDA Import Refusal data, there have been 0 import refusals issued for violation code 3884, affecting 0 unique firms.
When was the most recent refusal for violation 3884?
There is no recent refusal data available for violation 3884.
What products are commonly refused for violation 3884?
Various imported products may be refused under violation 3884 when they do not meet FDA requirements.
What is the legal basis for FDA violation code 3884?
Violation code 3884 is based on 801(a)(3);301(ll); PROHIBITED ACT 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.