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 | Metabolics Ltd | Devizes, UNITED KIN | 105 |
| 5 | Nestle India Limited | Bicholim, INDIA | 104 |
| 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 | Simsek Biskuvi ve gida sanayii A.s. | Karaman, TURKEY | 47 |
| 18 | Nestle India Limited - Moga Factory | Atari, INDIA | 47 |
| 19 | Shantou Olive Pharmaceutical Co.,Ltd | Shantou, CHINA | 46 |
| 20 | Nestle India Ltd | New Delhi, INDIA | 46 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/30/2025 | CORN CHIPS, FRIED 07BGT02 | Jocker's Foods IndustriesPHILIPPINE |
| 12/23/2025 | CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH FRUIT (WITHOUT CHOCOLATE) 33CYH05 | |
| 12/23/2025 | GUAVA, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT 21VFI04 | |
| 12/23/2025 | FRUIT COCTAIL, MIXED FRUIT, JUICES OR CONCENTRATES 21DFI01 | |
| 12/23/2025 | MANGO, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT 21VFI05 | |
| 12/23/2025 | PEANUT, SHELLED 23BGT07 | Jocker's Foods IndustriesPHILIPPINE |
| 12/17/2025 | MILK AND CREAM, N.E.C. 09CHT99 | |
| 12/16/2025 | SYRUP (PHARMACEUTIC NECESSITY - FLAVOR) 55QP13 | |
| 12/16/2025 | CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) 33SFY99 | cadbury nigeria plcNIGERIA |
| 12/16/2025 | ANTI-ECZEMATIC N.E.C. 61SBJ99 | |
| 12/16/2025 | MELON SEEDS (EDIBLE SEED PASTE) 23RGY05 | |
| 12/16/2025 | BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) 64LMJ06 | |
| 12/16/2025 | LEAF & STEM VEGETABLES, DRIED OR PASTE, N.E.C. 24UGH99 | |
| 12/16/2025 | PUMPKIN SEED (EDIBLE SEED) 23KGH01 | |
| 12/16/2025 | BEANS, CORN, AND PEA, N.E.C. (VEGETABLE) 24AYH99 |
Related Violations
Other violations under the same legal section: 403(i)(2), 801(a)(3); MISBRANDING
| Code | Charge Code | Cases |
|---|---|---|
| 329 | JUICE % | 727 |
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 20095 import refusals issued for violation code 218, affecting 7024 unique firms.
When was the most recent refusal for violation 218?
The most recent import refusal for violation 218 was on December 30, 2025.
What products are commonly refused for violation 218?
Products commonly refused under violation 218 include: CORN CHIPS, FRIED, CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH FRUIT (WITHOUT CHOCOLATE), GUAVA, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT, FRUIT COCTAIL, MIXED FRUIT, JUICES OR CONCENTRATES, MANGO, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT. 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.