Violation Code: 11
FDA Violation
Charge Code: UNSAFE COL
Violation Details
- Violation Code (ASC ID)
- 11
- Charge Code
- UNSAFE COL
- Description
- The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
- Legal Section
- 402(c), 801(a)(3); ADULTERATION
Most Affected Firms
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/31/2025 | JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) 33LFT07 | |
| 12/31/2025 | JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) 33LFT07 | |
| 12/31/2025 | NOODLES AND NOODLE PRODUCTS, N.E.C. 04CGT99 | Nutri-AsiaPHILIPPINE |
| 12/31/2025 | NOODLES AND NOODLE PRODUCTS, N.E.C. 04CGT99 | Nutri-AsiaPHILIPPINE |
| 12/30/2025 | CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) 33SGT99 | |
| 12/29/2025 | JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) 33LGT07 | Swizzels Matlow LimitedUNITED KIN |
| 12/29/2025 | JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) 33LGT07 | Swizzels Matlow LimitedUNITED KIN |
| 12/29/2025 | JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) 33LGT07 | Swizzels Matlow LimitedUNITED KIN |
| 12/29/2025 | JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) 33LGT07 | Swizzels Matlow LimitedUNITED KIN |
| 12/29/2025 | CANDY WITHOUT CHOCOLATE N.E.C. 33YGT99 | Swizzels Matlow LimitedUNITED KIN |
| 12/29/2025 | CANDY WITHOUT CHOCOLATE N.E.C. 33YGT99 | Swizzels Matlow LimitedUNITED KIN |
| 12/29/2025 | CANDY WITHOUT CHOCOLATE N.E.C. 33YGT99 | Swizzels Matlow LimitedUNITED KIN |
| 12/29/2025 | CORN CHIPS, FRIED 07BGT02 | |
| 12/29/2025 | CORN CHIPS, FRIED 07BGT02 | |
| 12/29/2025 | CORN CHIPS, FRIED 07BGT02 |
Frequently Asked Questions
What is FDA violation code 11?
11 is an FDA violation code that indicates: "The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).". This violation is based on 402(c), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 11?
According to FDA Import Refusal data, there have been 26251 import refusals issued for violation code 11, affecting 5526 unique firms.
When was the most recent refusal for violation 11?
The most recent import refusal for violation 11 was on December 31, 2025.
What products are commonly refused for violation 11?
Products commonly refused under violation 11 include: JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE), NOODLES AND NOODLE PRODUCTS, N.E.C., CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 11?
Violation code 11 is based on 402(c), 801(a)(3); ADULTERATION 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.