Violation Code: 482
FDA Violation
Charge Code: NUTRIT LBL
Violation Details
- Violation Code (ASC ID)
- 482
- Charge Code
- NUTRIT LBL
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
- Legal Section
- 403(q); 801(a)(3); Misbranding
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Cadbury Trebor Bassett | Birmingham, UNITED KIN | 631 |
| 2 | COMERCIALIZADORA PEPSICO | Ciudad De Mexico, MEXICO | 295 |
| 3 | Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco) | Tlajomulco De Zuniga, MEXICO | 220 |
| 4 | Nestle Food Service | York, UNITED KIN | 208 |
| 5 | Comercializadora Pepsico Mexico, | Ciudad De Mexico, MEXICO | 158 |
| 6 | H J Heinz Co Ltd | Hayes, UNITED KIN | 155 |
| 7 | Nutri-Asia, Incorporated dba UFC Philippines | Laguna, PHILIPPINE | 138 |
| 8 | Mars Confectionery Div Of Mars UK Ltd | Slough, UNITED KIN | 115 |
| 9 | Burton Foods Limited | Blackpool, UNITED KIN | 114 |
| 10 | Nestle India Limited | Bicholim, INDIA | 109 |
| 11 | Alnost Guatemala S.A | Guatemala, GUATEMALA | 83 |
| 12 | NisaWay / Bibby Distribution | Scunthorpe, UNITED KIN | 80 |
| 13 | Qwaider Packing & Trading Est | Amman, JORDAN | 79 |
| 14 | Oliver Olives, Inc. | Bolton, CANADA | 79 |
| 15 | UL Costa Rica SCC, S.A. | Heredia, COSTA RICA | 78 |
| 16 | Batleys plc | Salford, UNITED KIN | 77 |
| 17 | Fresh Hemp Foods, Ltd. | Winnipeg, CANADA | 77 |
| 18 | Nisa International | Grimsby, UNITED KIN | 73 |
| 19 | Rochef Chocolatier | Gatineau, CANADA | 70 |
| 20 | PHARMA GREEN S.R.L. | Falciano, ITALY | 70 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/22/2026 | OTHER FORMULA PRODUCTS, N.E.C., READY TO FEED 40NYY99 | Kendal Nutricare Ltd.UNITED KIN |
| 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 |
| 1/21/2026 | MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA 40PET01 | Hipp GmbH & CO Vertrieb KGGERMANY |
| 1/21/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCR99 | Tower Laboratories Ltd.UNITED STA |
| 1/21/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCR99 | LIOTECNICA TECNOLOGIA EMBRAZIL |
| 1/20/2026 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCH99 | |
| 1/20/2026 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCH99 | |
| 1/20/2026 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCH99 | |
| 1/20/2026 | WOLFBERRY (CHINESE OR SOUTHEAST ASIAN BERRY OF THE CHINESE MATRIMONY VINE, W/SLIGHT LICORICE FLAVOR) 20BYH24 | Gui Nan Hong Company LimitedHONG KONG |
| 1/20/2026 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FBT99 | Gui Nan Hong Company LimitedHONG KONG |
| 1/16/2026 | YANANG LEAVES (LEAF & STEM VEGETABLE) 24TEE41 | MAE KHEM CO LTDTHAILAND |
| 1/16/2026 | BAMBOO SHOOTS (LEAF & STEM VEGETABLE) 24TEE03 | MAE KHEM CO LTDTHAILAND |
| 1/16/2026 | BANANA (SUBTROPICAL AND TROPICAL FRUIT) 21SEE02 | MAE KHEM CO LTDTHAILAND |
| 1/16/2026 | BETEL LEAF (HERBAL AND BOTANICAL (NOT TEAS) II (CONTINUED)) 54KBY09 | MAE KHEM CO LTDTHAILAND |
Frequently Asked Questions
What is FDA violation code 482?
482 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 be misbranded in that the label or labeling fails to bear the required nutrition information.". This violation is based on 403(q); 801(a)(3); Misbranding of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 482?
According to FDA Import Refusal data, there have been 35751 import refusals issued for violation code 482, affecting 10323 unique firms.
When was the most recent refusal for violation 482?
The most recent import refusal for violation 482 was on January 22, 2026.
What products are commonly refused for violation 482?
Products commonly refused under violation 482 include: OTHER FORMULA PRODUCTS, N.E.C., READY TO FEED, MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULA, VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 482?
Violation code 482 is based on 403(q); 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.