Violation Code: 3422
FDA Violation
Charge Code: UNFIT4FOOD
Violation Details
- Violation Code (ASC ID)
- 3422
- Charge Code
- UNFIT4FOOD
- Description
- The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be unfit for food.
- Legal Section
- 402(a)(3), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | DONGGUAN HENGHUA FOOD CO.,LTD | Dongguan City, CHINA | 72 |
| 2 | Tsang Lin Industries Corp. | Taichung, TAIWAN | 63 |
| 3 | Labixiaoxin (Fujian) Foods Industrial Company Limited | Quanzhou, CHINA | 55 |
| 4 | Fujian Fuxing Industrial Imp. & Exp. Corp. | Fuzhou, CHINA | 41 |
| 5 | Zhuhai Camay Food Co., Ltd | Zhuhai City, CHINA | 37 |
| 6 | Boluo Lucky Food Co Ltd | Huizhou, CHINA | 37 |
| 7 | FUJIAN RUIYUN FOODS CO.,LTD | FUZHOU CITY, CHINA | 32 |
| 8 | Hebei Bailong Food Co., Ltd. | Xingtai, CHINA | 25 |
| 9 | GM FOOD LIMITED | San Po Kong, HONG KONG | 24 |
| 10 | Shanghai Mcvolf Food Co.,Ltd | Shanghai, CHINA | 20 |
| 11 | GUANGXI GUILIN ZHIREN FOOD INDUS | Guilin, CHINA | 20 |
| 12 | brilliant co.,ltd | Yanzhou, CHINA | 19 |
| 13 | XIAMEN HUI ER KANG FOOD CO., LTD. | Xiamen, CHINA | 19 |
| 14 | ANHUI NEW SELECT FOOD S&T DEVELO | Huaibei, CHINA | 18 |
| 15 | GUANGZHOU AOKUN FOOD CO.,LTD | Guangzhou, CHINA | 18 |
| 16 | M.M. Enterprise | Borsad, INDIA | 17 |
| 17 | Ka Xin Food Development Co.,Ltd | Zhuhai, CHINA | 17 |
| 18 | ZHANGJIAKOU CITY HENGHONG FOOD CO., LTD | Zhangjiakou, CHINA | 17 |
| 19 | New A Generation Foodstuffs(Xinhui) | Jiangmen, CHINA | 16 |
| 20 | FUZHOU SHENGLINMARK TRADE CO.,LTD. | Fuzhou, CHINA | 16 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/23/2025 | MIXED FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED, N.E.C. 21CHF99 | |
| 12/23/2025 | MIXED FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED, N.E.C. 21CHF99 | |
| 12/22/2025 | RICE PROTEIN 02DYT12 | |
| 12/16/2025 | CHOCOLATE FILLED/ICED COOKIES,BISCUITS AND WAFERS 03JGT02 | |
| 12/11/2025 | GEL CUPS, FRUIT FLAVORED W/FRUIT CANDY 33MCE03 | Jellico Food Co, Ltd.TAIWAN |
| 12/11/2025 | GEL CUPS, FRUIT FLAVORED W/FRUIT CANDY 33MCE03 | Jellico Food Co, Ltd.TAIWAN |
| 12/11/2025 | GEL CUPS, FRUIT FLAVORED W/FRUIT CANDY 33MCE03 | Jellico Food Co, Ltd.TAIWAN |
| 12/11/2025 | GEL CUPS, FRUIT FLAVORED W/FRUIT CANDY 33MCE03 | Jellico Food Co, Ltd.TAIWAN |
| 12/10/2025 | MIXED FRUIT FLAVORED IMITATION FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED 21NHY04 | |
| 12/10/2025 | MIXED FRUIT FLAVORED IMITATION FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED 21NHY04 | |
| 12/9/2025 | YOGURT (PLAIN, FLAVORED OR FRUIT ADDED) 09CCT15 | |
| 12/9/2025 | YOGURT (PLAIN, FLAVORED OR FRUIT ADDED) 09CGT15 | |
| 12/8/2025 | GELATIN, FLAVORED 35AGT01 | CORPORACION DEL VALLE METROPOLITANO S.A.COSTA RICA |
| 12/8/2025 | GELATIN, FLAVORED 35AGT01 | CORPORACION DEL VALLE METROPOLITANO S.A.COSTA RICA |
| 12/8/2025 | GELATIN, FLAVORED 35AGT01 | CORPORACION DEL VALLE METROPOLITANO S.A.COSTA RICA |
Related Violations
Other violations under the same legal section: 402(a)(3), 801(a)(3); ADULTERATION
Frequently Asked Questions
What is FDA violation code 3422?
3422 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 be unfit for food.". This violation is based on 402(a)(3), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3422?
According to FDA Import Refusal data, there have been 1472 import refusals issued for violation code 3422, affecting 372 unique firms.
When was the most recent refusal for violation 3422?
The most recent import refusal for violation 3422 was on December 23, 2025.
What products are commonly refused for violation 3422?
Products commonly refused under violation 3422 include: MIXED FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED, N.E.C., RICE PROTEIN, CHOCOLATE FILLED/ICED COOKIES,BISCUITS AND WAFERS, GEL CUPS, FRUIT FLAVORED W/FRUIT CANDY. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3422?
Violation code 3422 is based on 402(a)(3), 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.