Violation Code: 3400
FDA Violation
Charge Code: PB-FOOD
Violation Details
- Violation Code (ASC ID)
- 3400
- Charge Code
- PB-FOOD
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance, lead, which may render it injurious to health.
- Legal Section
- 402(a)(1); 801(a)(3); Adulteration
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Dulces Vero | Guadalajara, MEXICO | 26 |
| 2 | Gregoria Ramirez Hernandez | Guadalajara, MEXICO | 21 |
| 3 | SABRITAS, S.de R.L. de C.V. | Ciudad De Mexico, MEXICO | 20 |
| 4 | Graupera | Girona, SPAIN | 15 |
| 5 | UMEYOSHI | Hidaka-Gun, JAPAN | 14 |
| 6 | Productos Hola del Noroeste, S.A de C.V | Mexicali, MEXICO | 13 |
| 7 | Xebec Sails | Moradabad, INDIA | 11 |
| 8 | FULLTEN FOODS INDUSTRIES., LTD. | Chang Hwa, TAIWAN | 11 |
| 9 | Bueno Alimentos, S.A. de C.V. | Santa Catarina, MEXICO | 10 |
| 10 | National Foods | Karachi, PAKISTAN | 9 |
| 11 | Zi Jing Yuk Hin Enterprise Co., Ltd | Heyuan, CHINA | 9 |
| 12 | Brass Metal Crafters | Asdullapura, INDIA | 9 |
| 13 | Industrial de Alimentos Diana, SA de CV | Guadalajara, MEXICO | 9 |
| 14 | Productos Karla, S.A. de C.V. | Col. Tabasco, MEXICO | 9 |
| 15 | EL AZTECA DULCES Y GOLOSINAS DE MEXICO SA DE CV | Guadalajara, MEXICO | 8 |
| 16 | Productos de Leche San Pablo,S.A. de C.V. | Linares, MEXICO | 8 |
| 17 | TAIWAN SHUNTAI FOOD CO., LTD. | Ta Tsun, TAIWAN | 7 |
| 18 | Cuanda, S.A. DE C.V. | Santa Cruz De Juventino Rosas, MEXICO | 6 |
| 19 | United Trading Company | Moradabad, INDIA | 6 |
| 20 | DHARA FOODS PVT .LTD | Anand, INDIA | 6 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 11/18/2025 | CINNAMON, CASSIA, GROUND, CRACKED (SPICE) 28BGH13 | |
| 11/18/2025 | CINNAMON, CASSIA, GROUND, CRACKED (SPICE) 28BGN13 | E-SILK ROUTE VENTURES (PVT) LTD.SRI LANKA |
| 9/2/2025 | CINNAMON, CASSIA, WHOLE (SPICE) 28ADT13 | DHARA FOODS PVT .LTDINDIA |
| 8/5/2025 | CINNAMON, CASSIA, WHOLE (SPICE) 28ADT13 | DHARA FOODS PVT .LTDINDIA |
| 7/10/2025 | CINNAMON, CASSIA, WHOLE (SPICE) 28ADT13 | DHARA FOODS PVT .LTDINDIA |
| 5/19/2025 | STORAGE CONTAINERS (W/ OR W/O LID), (FOODWARE, COOKWARE & TABLEWARE) 52AIE34 | |
| 5/19/2025 | STORAGE CONTAINERS (W/ OR W/O LID), (FOODWARE, COOKWARE & TABLEWARE) 52AIE34 | |
| 4/18/2025 | CINNAMON, CASSIA, GROUND, CRACKED (SPICE) 28BGT13 | DK Foods CompanyVIETNAM |
| 3/31/2025 | HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) 33EGT99 | |
| 3/12/2025 | MOLE PASTE 37KHT18 | |
| 2/24/2025 | MOLE PASTE 37KHT18 | |
| 2/4/2025 | CINNAMON, CASSIA, GROUND, CRACKED (SPICE) 28BFT13 | PT Dwi Sejahtera NusantaraINDONESIA |
| 1/28/2025 | MOLE PASTE 37KHT18 | |
| 1/24/2025 | PLATES, ANY SIZE (FOODWARE, COOKWARE & TABLEWARE) 52AIE28 | PLATE CERAMIC & ARTMEXICO |
| 1/24/2025 | SPECIALTY DISH, W/FOOT (FOR FOOD USE, E.G., ICE CREAM DISH W/FOOT), (FOODWARE, COOKWARE & TABLEWARE) 52AIE35 | PLATE CERAMIC & ARTMEXICO |
Related Violations
Other violations under the same legal section: 402(a)(1); 801(a)(3); Adulteration
| Code | Charge Code | Cases |
|---|---|---|
| 2420 | RADIONUC | 101 |
Frequently Asked Questions
What is FDA violation code 3400?
3400 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 contain a poisonous or deleterious substance, lead, which may render it injurious to health.". This violation is based on 402(a)(1); 801(a)(3); Adulteration of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3400?
According to FDA Import Refusal data, there have been 560 import refusals issued for violation code 3400, affecting 247 unique firms.
When was the most recent refusal for violation 3400?
The most recent import refusal for violation 3400 was on November 18, 2025.
What products are commonly refused for violation 3400?
Products commonly refused under violation 3400 include: CINNAMON, CASSIA, GROUND, CRACKED (SPICE), CINNAMON, CASSIA, WHOLE (SPICE). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3400?
Violation code 3400 is based on 402(a)(1); 801(a)(3); Adulteration 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.