Violation Code: 258
FDA Violation
Charge Code: FLAVR LBLG
Violation Details
- Violation Code (ASC ID)
- 258
- Charge Code
- FLAVR LBLG
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain an artificial flavoring and it fails to bear labeling stating that fact.
- Legal Section
- 403(k), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Cadbury Trebor Bassett | Birmingham, UNITED KIN | 72 |
| 2 | Nestle Food Service | York, UNITED KIN | 24 |
| 3 | Jiangmen Ziqiao Food Ltd. | Taishan, CHINA | 16 |
| 4 | Moments Industries | Mumbai, INDIA | 13 |
| 5 | Mars Confectionery Div Of Mars UK Ltd | Slough, UNITED KIN | 13 |
| 6 | Centura Food | Egham, UNITED KIN | 12 |
| 7 | Turner and Wrights Ltd | Bolton, UNITED KIN | 11 |
| 8 | TREBOR BASSETT LTD | BIRMINGHAM, UNITED KIN | 10 |
| 9 | Taokaenoi Food & Marketing Co.,Ltd. | Nonthaburi, THAILAND | 8 |
| 10 | V.K.ENTERPRISE | Mumbai, INDIA | 8 |
| 11 | Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco) | Tlajomulco De Zuniga, MEXICO | 8 |
| 12 | Fujian Ranli Food Group Co. Ltd. | Zhangzhou, CHINA | 7 |
| 13 | MTR Foods Private Limited | Bangalore, INDIA | 6 |
| 14 | Fantasy Toys And Candies | Shantou City, CHINA | 6 |
| 15 | Aleshin E.O | Abakan, RUSSIA | 5 |
| 16 | CADBURY | Birmingham, UNITED KIN | 5 |
| 17 | HUBEI LIANGPIN SHOP FOOD INDSUTR | Hubei Province, CHINA | 5 |
| 18 | S.H.I. CHINA, LTD | Dong Guan City, CHINA | 5 |
| 19 | HP Foods PLC | Birmingham, UNITED KIN | 5 |
| 20 | Alipro AG | Hittnau, SWITZERLAN | 4 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/23/2025 | JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) 33LYY07 | |
| 10/28/2025 | CARBONATED SOFT DRINK, N.E.C. 29BHT99 | |
| 10/20/2025 | CARBONATED SOFT DRINK, N.E.C. 29BGT99 | |
| 10/20/2025 | WINE, SPARKLING (NATURALLY CARBONATED) 32BCP05 | |
| 10/20/2025 | WINE, SPARKLING (NATURALLY CARBONATED) 32BCP05 | |
| 9/18/2025 | MIXED PLAIN COOKIES,BISCUITS AND WAFERS 03HGT07 | WEMBS MARKETING SDN BHDMALAYSIA |
| 9/18/2025 | FILLED CRACKERS N.E.C. 03GGT99 | WEMBS MARKETING SDN BHDMALAYSIA |
| 8/29/2025 | CANDY WITHOUT CHOCOLATE N.E.C. 33YGT99 | CROWN JINCHEON FACTORYSOUTH KORE |
| 8/29/2025 | CANDY WITHOUT CHOCOLATE N.E.C. 33YGT99 | CROWN JINCHEON FACTORYSOUTH KORE |
| 8/15/2025 | CAKE WITHOUT CUSTARD OR CREAM FILLING 03RGT01 | |
| 8/15/2025 | CAKE WITHOUT CUSTARD OR CREAM FILLING 03RGT01 | |
| 8/5/2025 | CAKE WITHOUT CUSTARD OR CREAM FILLING 03RGT01 | |
| 7/23/2025 | CORN CHIPS, FRIED 07BDT02 | |
| 7/23/2025 | CORN CHIPS, FRIED 07BDT02 | BARCEL, S.A. DE C.VMEXICO |
| 7/23/2025 | CORN CHIPS, FRIED 07BDT02 | BARCEL, S.A. DE C.VMEXICO |
Related Violations
Other violations under the same legal section: 403(k), 801(a)(3); MISBRANDING
Frequently Asked Questions
What is FDA violation code 258?
258 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 contain an artificial flavoring and it fails to bear labeling stating that fact.". This violation is based on 403(k), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 258?
According to FDA Import Refusal data, there have been 509 import refusals issued for violation code 258, affecting 206 unique firms.
When was the most recent refusal for violation 258?
The most recent import refusal for violation 258 was on December 23, 2025.
What products are commonly refused for violation 258?
Products commonly refused under violation 258 include: JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE), CARBONATED SOFT DRINK, N.E.C., WINE, SPARKLING (NATURALLY CARBONATED). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 258?
Violation code 258 is based on 403(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.