Violation Code: 3603
FDA Violation
Charge Code: OTHER DRUG
Violation Details
- Violation Code (ASC ID)
- 3603
- Charge Code
- OTHER DRUG
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article is a drug and if it is offered for sale under the name of another drug.
- Legal Section
- 502(i) (3), 801(a)(3); MISBRANDING
Frequently Asked Questions
What is FDA violation code 3603?
3603 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article is a drug and if it is offered for sale under the name of another drug.". This violation is based on 502(i) (3), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3603?
According to FDA Import Refusal data, there have been 0 import refusals issued for violation code 3603, affecting 0 unique firms.
When was the most recent refusal for violation 3603?
There is no recent refusal data available for violation 3603.
What products are commonly refused for violation 3603?
Various imported products may be refused under violation 3603 when they do not meet FDA requirements.
What is the legal basis for FDA violation code 3603?
Violation code 3603 is based on 502(i) (3), 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.