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 |
|---|---|---|
| 1/22/2026 | FRUIT FILLED FILLED/ICED COOKIES,BISCUITS AND WAFERS 03JGT06 | Dare FoodsCANADA |
| 1/22/2026 | FLAVORED CANDY, SOFT (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) 33LGT06 | HERHEYUNITED STA |
| 1/21/2026 | BEVERAGE BASE, CITRUS, LIQUID 30BHT02 | Pepsico IncUNITED STA |
| 1/21/2026 | CAKE WITHOUT CUSTARD OR CREAM FILLING 03RGT01 | PURE PROTEINUNITED STA |
| 1/21/2026 | SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) 33LGT99 | |
| 1/21/2026 | MIXED DRINKS (NONALCOHOLIC BEVERAGES) 29CET04 | LAJTHIZA INVEST SHAALBANIA |
| 1/21/2026 | CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) 33EFT05 | Mars, IncorporatedUNITED STA |
| 1/20/2026 | CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) 33SGT99 | Bubs GodisSWEDEN |
| 1/20/2026 | CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) 33SGT99 | Bubs GodisSWEDEN |
| 1/20/2026 | CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) 33SGT99 | Bubs GodisSWEDEN |
| 1/20/2026 | FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) 33EGT06 | |
| 1/20/2026 | CHOCOLATE CANDY BAR, WITH NUTS OR NUT PRODUCTS (NOT COCONUT) 34CFY01 | |
| 1/20/2026 | CHOCOLATE CANDY BAR, WITH NUTS OR NUT PRODUCTS (NOT COCONUT) 34CFY01 | |
| 1/20/2026 | CHEWING GUM (WITHOUT CHOCOLATE) 33UYT02 | Indaco S.p.A.ITALY |
| 1/20/2026 | CORN CHIPS, FRIED 07BGT02 | BARCEL, S.A. DE C.VMEXICO |
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 26347 import refusals issued for violation code 11, affecting 5545 unique firms.
When was the most recent refusal for violation 11?
The most recent import refusal for violation 11 was on January 22, 2026.
What products are commonly refused for violation 11?
Products commonly refused under violation 11 include: FRUIT FILLED FILLED/ICED COOKIES,BISCUITS AND WAFERS, FLAVORED CANDY, SOFT (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE), BEVERAGE BASE, CITRUS, LIQUID, CAKE WITHOUT CUSTARD OR CREAM FILLING, SOFT CANDY WITHOUT NUTS AND FRUIT, 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.