Violation Code: 218
FDA Violation
Charge Code: LIST INGRE
Violation Details
- Violation Code (ASC ID)
- 218
- Charge Code
- LIST INGRE
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
- Legal Section
- 403(i)(2), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Cadbury Trebor Bassett | Birmingham, UNITED KIN | 231 |
| 2 | COMERCIALIZADORA PEPSICO | Ciudad De Mexico, MEXICO | 143 |
| 3 | Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco) | Tlajomulco De Zuniga, MEXICO | 117 |
| 4 | Nestle India Limited | Bicholim, INDIA | 106 |
| 5 | Metabolics Ltd | Devizes, UNITED KIN | 105 |
| 6 | BRITANNIA INDUSTRIES LIMITED | Kolkata, INDIA | 87 |
| 7 | Samyang Foods Co Ltd | Seoul, SOUTH KORE | 84 |
| 8 | Haldiram Exports (Pvt) Limited | New Delhi, INDIA | 78 |
| 9 | Comercializadora Pepsico Mexico, | Ciudad De Mexico, MEXICO | 72 |
| 10 | Ravi Spice Processors Pvt Ltd. | Bengaluru, INDIA | 67 |
| 11 | PHARMA GREEN S.R.L. | Falciano, ITALY | 66 |
| 12 | FarmGroup | Barnaul, RUSSIA | 60 |
| 13 | PJ Exports | Bhiwandi, INDIA | 58 |
| 14 | DHARA FOODS PVT .LTD | Anand, INDIA | 56 |
| 15 | Chokoladespecialisten Kbh A/S | Taastrup, DENMARK | 52 |
| 16 | Mars Confectionery Div Of Mars UK Ltd | Slough, UNITED KIN | 50 |
| 17 | Nestle India Limited - Moga Factory | Atari, INDIA | 49 |
| 18 | Simsek Biskuvi ve gida sanayii A.s. | Karaman, TURKEY | 47 |
| 19 | Shantou Olive Pharmaceutical Co.,Ltd | Shantou, CHINA | 46 |
| 20 | Nestle India Ltd | New Delhi, INDIA | 46 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/22/2026 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PET01 | Holle Baby Food GmbHSWITZERLAN |
| 1/22/2026 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PET01 | Holle Baby Food GmbHSWITZERLAN |
| 1/22/2026 | TEA, BLACK 31KYT01 | |
| 1/21/2026 | CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) 33SYY99 | |
| 1/20/2026 | TEA, BLACK 31KYY01 | Tonic Life S de RLMEXICO |
| 1/16/2026 | CURRY PASTE 37KCN23 | MAE KHEM CO LTDTHAILAND |
| 1/16/2026 | CURRY PASTE 37KCN23 | MAE KHEM CO LTDTHAILAND |
| 1/15/2026 | CAKE WITHOUT CUSTARD OR CREAM FILLING 03RGT01 | |
| 1/15/2026 | CAKE WITHOUT CUSTARD OR CREAM FILLING 03RGT01 | |
| 1/15/2026 | TEA, LIQUID 31KHT20 | |
| 1/14/2026 | CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) 33EFT05 | Mars, IncorporatedUNITED STA |
| 1/14/2026 | JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) 33LGT07 | MONDELEZ INTERNATIONALUNITED STA |
| 1/14/2026 | JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) 33LGT07 | MONDELEZ INTERNATIONALUNITED STA |
| 1/14/2026 | JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) 33LGT07 | The Hershey CompanyUNITED STA |
| 1/12/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | Seishin Seiyaku Co.JAPAN |
Related Violations
Other violations under the same legal section: 403(i)(2), 801(a)(3); MISBRANDING
| Code | Charge Code | Cases |
|---|---|---|
| 329 | JUICE % | 728 |
Frequently Asked Questions
What is FDA violation code 218?
218 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.". This violation is based on 403(i)(2), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 218?
According to FDA Import Refusal data, there have been 20143 import refusals issued for violation code 218, affecting 7040 unique firms.
When was the most recent refusal for violation 218?
The most recent import refusal for violation 218 was on January 22, 2026.
What products are commonly refused for violation 218?
Products commonly refused under violation 218 include: MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA, TEA, BLACK, 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 218?
Violation code 218 is based on 403(i)(2), 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.