Violation Code: 283
FDA Violation
Charge Code: INSULIN
Violation Details
- Violation Code (ASC ID)
- 283
- Charge Code
- INSULIN
- Description
- The drug appears to purport, or represented as, being composed wholly or partly of insulin and it does not appear to be from a batch with respect to which a certificate or release has been issued pursuant to section 506.REPEALED 11/97
- Legal Section
- 502(k), 801(a)(3); MISBRANDING
Frequently Asked Questions
What is FDA violation code 283?
283 is an FDA violation code that indicates: "The drug appears to purport, or represented as, being composed wholly or partly of insulin and it does not appear to be from a batch with respect to which a certificate or release has been issued pursuant to section 506.REPEALED 11/97". This violation is based on 502(k), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 283?
According to FDA Import Refusal data, there have been 0 import refusals issued for violation code 283, affecting 0 unique firms.
When was the most recent refusal for violation 283?
There is no recent refusal data available for violation 283.
What products are commonly refused for violation 283?
Various imported products may be refused under violation 283 when they do not meet FDA requirements.
What is the legal basis for FDA violation code 283?
Violation code 283 is based on 502(k), 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.