Violation Code: 3421
FDA Violation
Charge Code: MELAMINE
Violation Details
- Violation Code (ASC ID)
- 3421
- Charge Code
- MELAMINE
- Description
- The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the meaning of section 409.
- Legal Section
- 402(a)(2)(C)(i), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Five Heros Pet Industries Inc | Taipei, TAIWAN | 101 |
| 2 | DONGGUAN HENGHUA FOOD CO.,LTD | Dongguan City, CHINA | 82 |
| 3 | FUJIAN RUIYUN FOODS CO.,LTD | FUZHOU CITY, CHINA | 50 |
| 4 | Fujian Fuxing Industrial Imp. & Exp. Corp. | Fuzhou, CHINA | 42 |
| 5 | Cadbury India Limited | Mumbai, INDIA | 41 |
| 6 | Boluo Lucky Food Co Ltd | Huizhou, CHINA | 40 |
| 7 | Zhuhai Camay Food Co., Ltd | Zhuhai City, CHINA | 38 |
| 8 | DASENLIN FOOD CO., LTD | Jilin, CHINA | 30 |
| 9 | Anhui Lejinji Food CO., LTD | Hefei, CHINA | 28 |
| 10 | GM FOOD LIMITED | San Po Kong, HONG KONG | 26 |
| 11 | Hebei Bailong Food Co., Ltd. | Xingtai, CHINA | 25 |
| 12 | Jiangmen Ziqiao Food Ltd. | Taishan, CHINA | 24 |
| 13 | Shanghai Jiangqi Glico Minfa Food Co., Ltd. | Shanghai, CHINA | 24 |
| 14 | FUZHOU SHENGLINMARK TRADE CO.,LTD. | Fuzhou, CHINA | 23 |
| 15 | Zhongshan Qiquyuan Food Co., Ltd. | Zhongshan, CHINA | 23 |
| 16 | XIAMEN HUI ER KANG FOOD CO., LTD. | Xiamen, CHINA | 22 |
| 17 | CAMRY (ZHUHAI) PACKING CO.,LTD | Zhuhai, CHINA | 22 |
| 18 | Shanghai Mcvolf Food Co.,Ltd | Shanghai, CHINA | 22 |
| 19 | Shanghai Doking Food Co. Ltd. | Shangqiu, CHINA | 21 |
| 20 | Marigold Manufacturing Corporation | Pasig, PHILIPPINE | 21 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/31/2025 | MILK AND MILK PRODUCTS, CULTURED OR ACIDIFIED 09DGY26 | |
| 12/31/2025 | MILK BREAD/ROLLS/BUNS 03AGT08 | |
| 12/31/2025 | RICE GRAIN SNACK (WHOLE, SPLIT), FRIED/OIL COOKED 07JGT03 | |
| 12/31/2025 | RICE GRAIN SNACK (WHOLE, SPLIT), FRIED/OIL COOKED 07JGT03 | |
| 12/31/2025 | RICE GRAIN SNACK (WHOLE, SPLIT), FRIED/OIL COOKED 07JGT03 | |
| 12/23/2025 | RICE GRAIN SNACK (WHOLE, SPLIT), BAKED 07IGT03 | |
| 12/16/2025 | OTHER PET FOOD, N.E.C. 72EYY99 | |
| 12/16/2025 | OTHER PET FOOD, N.E.C. 72EYY99 | |
| 12/16/2025 | CHOCOLATE FILLED/ICED COOKIES,BISCUITS AND WAFERS 03JGT02 | |
| 12/15/2025 | OTHER FORMULA PRODUCTS, N.E.C., POWDER FORMULA 40PME99 | |
| 12/15/2025 | CAKE WITHOUT CUSTARD OR CREAM FILLING 03RGT01 | |
| 12/13/2025 | SOFT DRINK, MILK BASED (CHOCOLATE FLAVORED, ETC.), NONCARBONATED 29AGT70 | |
| 12/13/2025 | SOFT DRINK, MILK BASED (CHOCOLATE FLAVORED, ETC.), NONCARBONATED 29AGT70 | |
| 12/13/2025 | CAKE WITHOUT CUSTARD OR CREAM FILLING 03RGT01 | |
| 12/12/2025 | FLUID/DRY MILK PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C. 09YYO99 |
Related Violations
Other violations under the same legal section: 402(a)(2)(C)(i), 801(a)(3); ADULTERATION
Frequently Asked Questions
What is FDA violation code 3421?
3421 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 bear or contain a food additive, namely melamine and/or a melamine analog, that is unsafe within the meaning of section 409.". This violation is based on 402(a)(2)(C)(i), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3421?
According to FDA Import Refusal data, there have been 2880 import refusals issued for violation code 3421, affecting 682 unique firms.
When was the most recent refusal for violation 3421?
The most recent import refusal for violation 3421 was on December 31, 2025.
What products are commonly refused for violation 3421?
Products commonly refused under violation 3421 include: MILK AND MILK PRODUCTS, CULTURED OR ACIDIFIED, MILK BREAD/ROLLS/BUNS, RICE GRAIN SNACK (WHOLE, SPLIT), FRIED/OIL COOKED. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3421?
Violation code 3421 is based on 402(a)(2)(C)(i), 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.