Violation Code: 328
FDA Violation
Charge Code: USUAL NAME
Violation Details
- Violation Code (ASC ID)
- 328
- Charge Code
- USUAL NAME
- 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)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.
- Legal Section
- 403(i)(1), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | COMERCIALIZADORA PEPSICO | Ciudad De Mexico, MEXICO | 86 |
| 2 | Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco) | Tlajomulco De Zuniga, MEXICO | 64 |
| 3 | Chokoladespecialisten Kbh A/S | Taastrup, DENMARK | 51 |
| 4 | Shantou Olive Pharmaceutical Co.,Ltd | Shantou, CHINA | 46 |
| 5 | Holw El Sham | Cairo, EGYPT | 38 |
| 6 | Square Consumer Products ltd | Dhaka, BANGLADESH | 33 |
| 7 | Sudip And Company | Mumbai, INDIA | 32 |
| 8 | NEVA CONFECTIONERY | Sankt-Peterburg, RUSSIA | 32 |
| 9 | Maabarot Products Ltd. | Ma'Abarot, ISRAEL | 31 |
| 10 | Comercializadora Pepsico Mexico, | Ciudad De Mexico, MEXICO | 29 |
| 11 | Agroalimentos Fresh Harvest SA de CV | Culiacan, MEXICO | 28 |
| 12 | Comercial Artesana Sosa | Barcelona, SPAIN | 27 |
| 13 | Maestri Pasta/G.A.C. Srl | Mercato San Severino, ITALY | 25 |
| 14 | Three Squirrels Inc. | Wuhu, CHINA | 24 |
| 15 | Veerprabhu Export House | Mumbai, INDIA | 22 |
| 16 | Nestle India Limited | Bicholim, INDIA | 22 |
| 17 | GM FOOD LIMITED | San Po Kong, HONG KONG | 21 |
| 18 | Confiserie Sprungli AG | Dietikon, SWITZERLAN | 20 |
| 19 | Nutri-Asia, Incorporated dba UFC Philippines | Laguna, PHILIPPINE | 19 |
| 20 | Abu Odeh Bros. Co. Ltd | Amman, JORDAN | 19 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/30/2025 | CORN CHIPS, FRIED 07BGT02 | Jocker's Foods IndustriesPHILIPPINE |
| 12/30/2025 | FISH, N.E.C. 16AGD99 | |
| 12/30/2025 | FISH, N.E.C. 16AGD99 | |
| 12/30/2025 | FISH, N.E.C. 16AGD99 | |
| 12/30/2025 | FISH, N.E.C. 16AGD99 | |
| 12/23/2025 | FRUIT COCTAIL, MIXED FRUIT, JUICES OR CONCENTRATES 21DFI01 | |
| 12/18/2025 | FISH, HOT SMOKED N.E.C. 16IGH99 | ZIDADU TRADINGTANZANIA |
| 12/17/2025 | MUD FISH 16AGT64 | |
| 12/17/2025 | MUD FISH 16AGT64 | |
| 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 |
Frequently Asked Questions
What is FDA violation code 328?
328 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)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.". This violation is based on 403(i)(1), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 328?
According to FDA Import Refusal data, there have been 7093 import refusals issued for violation code 328, affecting 3028 unique firms.
When was the most recent refusal for violation 328?
The most recent import refusal for violation 328 was on December 30, 2025.
What products are commonly refused for violation 328?
Products commonly refused under violation 328 include: CORN CHIPS, FRIED, FISH, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 328?
Violation code 328 is based on 403(i)(1), 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.