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 |
|---|---|---|
| 1/20/2026 | TEA, BLACK 31KYY01 | Tonic Life S de RLMEXICO |
| 1/16/2026 | PAPAYA (PAPAW) (SUBTROPICAL AND TROPICAL FRUIT PUREES) 21REE06 | MAE KHEM CO LTDTHAILAND |
| 1/14/2026 | SWEET GOODS,CUSTARD OR CREAM FILLED, N.E.C. 03NGT99 | |
| 1/12/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | Seishin Seiyaku Co.JAPAN |
| 1/12/2026 | TEA, INSTANT, PLAIN 31KYT30 | Tonic Life S de RLMEXICO |
| 1/12/2026 | TEA, INSTANT, PLAIN 31KYT30 | Tonic Life S de RLMEXICO |
| 1/9/2026 | SOFT DRINK, MILK BASED (CHOCOLATE FLAVORED, ETC.), NONCARBONATED 29AGT70 | NESTLE NIGERIANIGERIA |
| 1/9/2026 | SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C. 07YGT99 | |
| 1/7/2026 | CITRUS FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER AND CANDIED, N.E.C. 20JYT99 | PANADERIA LOS TRILLIZOS SA DE CVEL SALVADO |
| 1/5/2026 | CARBONATED SOFT DRINK, N.E.C. 29BET99 | |
| 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 | |
| 12/30/2025 | CORN CHIPS, FRIED 07BGT02 | Jocker's Foods IndustriesPHILIPPINE |
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 7103 import refusals issued for violation code 328, affecting 3032 unique firms.
When was the most recent refusal for violation 328?
The most recent import refusal for violation 328 was on January 20, 2026.
What products are commonly refused for violation 328?
Products commonly refused under violation 328 include: TEA, BLACK, PAPAYA (PAPAW) (SUBTROPICAL AND TROPICAL FRUIT PUREES), SWEET GOODS,CUSTARD OR CREAM FILLED, N.E.C., VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C., TEA, INSTANT, PLAIN. 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.