Violation Code: 321
FDA Violation
Charge Code: LACKS N/C
Violation Details
- Violation Code (ASC ID)
- 321
- Charge Code
- LACKS N/C
- 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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
- Legal Section
- 403(e)(2), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Cadbury Trebor Bassett | Birmingham, UNITED KIN | 601 |
| 2 | Nestle Food Service | York, UNITED KIN | 193 |
| 3 | H J Heinz Co Ltd | Hayes, UNITED KIN | 144 |
| 4 | Mars Confectionery Div Of Mars UK Ltd | Slough, UNITED KIN | 108 |
| 5 | Burton Foods Limited | Blackpool, UNITED KIN | 106 |
| 6 | Nestle India Limited | Bicholim, INDIA | 83 |
| 7 | Oliver Olives, Inc. | Bolton, CANADA | 80 |
| 8 | Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco) | Tlajomulco De Zuniga, MEXICO | 80 |
| 9 | Batleys plc | Salford, UNITED KIN | 73 |
| 10 | NisaWay / Bibby Distribution | Scunthorpe, UNITED KIN | 72 |
| 11 | Turner and Wrights Ltd | Bolton, UNITED KIN | 53 |
| 12 | Glaxosmithkline | Brentford, UNITED KIN | 52 |
| 13 | Chokoladespecialisten Kbh A/S | Taastrup, DENMARK | 52 |
| 14 | Premier Foods Limited (Long Sutton Site) | Spalding, UNITED KIN | 49 |
| 15 | Veerprabhu Export House | Mumbai, INDIA | 49 |
| 16 | Walkers' Nonsuch Limited | Stoke-On-Trent, UNITED KIN | 48 |
| 17 | Sun Mark Ltd | Greenford, UNITED KIN | 45 |
| 18 | Holw El Sham | Cairo, EGYPT | 44 |
| 19 | CADBURY | Birmingham, UNITED KIN | 41 |
| 20 | Hipp GmbH & CO Vertrieb KG | Pfaffenhofen A.d.ilm, GERMANY | 41 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/23/2025 | MACAROON,PREPARED DRY COOKIE, BISCUITS AND WAFER MIXES WITH MILK OR EGGS 03KYH11 | |
| 12/23/2025 | CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) 33SYY99 | |
| 12/23/2025 | CAKE DOUGH OR BATTER WITHOUT CUSTARD OR CREAM FILLING 03TYY01 | |
| 12/23/2025 | CAKE DOUGH OR BATTER WITHOUT CUSTARD OR CREAM FILLING 03TYY01 | |
| 12/23/2025 | CAKE DOUGH OR BATTER WITHOUT CUSTARD OR CREAM FILLING 03TYY01 | |
| 12/23/2025 | KIWANO MELON (ENGLISH TOMATO) 22BYH08 | |
| 12/23/2025 | KIWI FRUIT, DRIED OR PASTE 21TYH11 | |
| 12/23/2025 | MARSHMALLOW CANDY, HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) 33EYH09 | |
| 12/23/2025 | OTHER FRUIT AND FRUIT PRODUCTS, DRIED AND PASTE, N.E.C. 22HYH99 | |
| 12/23/2025 | ORANGE (CITRUS) 20GYY06 | |
| 12/23/2025 | OTHER FRUIT AND FRUIT PRODUCTS, DRIED AND PASTE, N.E.C. 22HYH99 | |
| 12/23/2025 | JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) 33LYY07 | |
| 12/23/2025 | CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH FRUIT (WITHOUT CHOCOLATE) 33CYH05 | |
| 12/17/2025 | MUD FISH 16AGT64 | |
| 12/17/2025 | MUD FISH 16AGT64 |
Frequently Asked Questions
What is FDA violation code 321?
321 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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.". This violation is based on 403(e)(2), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 321?
According to FDA Import Refusal data, there have been 16110 import refusals issued for violation code 321, affecting 5200 unique firms.
When was the most recent refusal for violation 321?
The most recent import refusal for violation 321 was on December 23, 2025.
What products are commonly refused for violation 321?
Products commonly refused under violation 321 include: MACAROON,PREPARED DRY COOKIE, BISCUITS AND WAFER MIXES WITH MILK OR EGGS, CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE), CAKE DOUGH OR BATTER WITHOUT CUSTARD OR CREAM FILLING. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 321?
Violation code 321 is based on 403(e)(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.