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Violation Code: 3421

FDA Violation

Charge Code: MELAMINE

2,966
Total Refusals
697
Affected Firms
1/21/2026
Latest Case
10/27/2008
First Case

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 NameLocationCases
1Five Heros Pet Industries IncTaipei, TAIWAN101
2DONGGUAN HENGHUA FOOD CO.,LTDDongguan City, CHINA82
3FUJIAN RUIYUN FOODS CO.,LTDFUZHOU CITY, CHINA50
4Fujian Fuxing Industrial Imp. & Exp. Corp.Fuzhou, CHINA42
5Cadbury India LimitedMumbai, INDIA41
6Boluo Lucky Food Co LtdHuizhou, CHINA40
7Zhuhai Camay Food Co., LtdZhuhai City, CHINA38
8LEYUAN HEALTH TECHNOLOGY HUZHOUCOMPANY LIMITEDZhejiang, CHINA36
9DASENLIN FOOD CO., LTDJilin, CHINA30
10Anhui Lejinji Food CO., LTDHefei, CHINA28
11GM FOOD LIMITEDSan Po Kong, HONG KONG26
12Hebei Bailong Food Co., Ltd.Xingtai, CHINA25
13Jiangmen Ziqiao Food Ltd.Taishan, CHINA24
14Shanghai Jiangqi Glico Minfa Food Co., Ltd.Shanghai, CHINA24
15Zhongshan Qiquyuan Food Co., Ltd.Zhongshan, CHINA23
16FUZHOU SHENGLINMARK TRADE CO.,LTD.Fuzhou, CHINA23
17Forest Foods Co., Ltd.Jilin, CHINA23
18CAMRY (ZHUHAI) PACKING CO.,LTDZhuhai, CHINA22
19XIAMEN HUI ER KANG FOOD CO., LTD.Xiamen, CHINA22
20Shanghai Mcvolf Food Co.,LtdShanghai, CHINA22

Recent Import Refusals

DateProductFirm
1/21/2026
GOAT MILK BASED INFANT FORMULA PRODUCT (0-12 MONTHS), READY TO FEED
40NYY05
GOLDEN PARTNER MEALCHINA
1/20/2026
BREAD/ROLLS/BUNS, N.E.C.
03AGT99
Hangzhou Daoyun Food Technology Co., LtdCHINA
1/20/2026
BREAD/ROLLS/BUNS, N.E.C.
03AGT99
Hangzhou Daoyun Food Technology Co., LtdCHINA
1/20/2026
NONCARBONATED SOFT DRINK, N.E.C.
29AHT99
LEYUAN HEALTH TECHNOLOGY HUZHOUCOMPANY LIMITEDCHINA
1/20/2026
NONCARBONATED SOFT DRINK, N.E.C.
29AHT99
LEYUAN HEALTH TECHNOLOGY HUZHOUCOMPANY LIMITEDCHINA
1/20/2026
CAKE,CUSTARD OR CREAM FILLED
03NGT01
LEYUAN HEALTH TECHNOLOGY HUZHOUCOMPANY LIMITEDCHINA
1/20/2026
CAKE,CUSTARD OR CREAM FILLED
03NGT01
LEYUAN HEALTH TECHNOLOGY HUZHOUCOMPANY LIMITEDCHINA
1/20/2026
CAKE,CUSTARD OR CREAM FILLED
03NGT01
LEYUAN HEALTH TECHNOLOGY HUZHOUCOMPANY LIMITEDCHINA
1/20/2026
POTATO SNACKS (FLAVORED OR UNFLAVORED), VEGETABLE SNACKS (OTHER THAN PULSES) BAKED
07QGT07
LEYUAN HEALTH TECHNOLOGY HUZHOUCOMPANY LIMITEDCHINA
1/20/2026
ICING AND ICING MIXES WITHOUT CHOCOLATE OR NUTS
03UCY01
LEYUAN HEALTH TECHNOLOGY HUZHOUCOMPANY LIMITEDCHINA
1/20/2026
RICE GRAIN SNACK (WHOLE, SPLIT), FRIED/OIL COOKED
07JGT03
LEYUAN HEALTH TECHNOLOGY HUZHOUCOMPANY LIMITEDCHINA
1/20/2026
CAKE,CUSTARD OR CREAM FILLED
03NGT01
LEYUAN HEALTH TECHNOLOGY HUZHOUCOMPANY LIMITEDCHINA
1/20/2026
BREAD/ROLLS/BUNS, N.E.C.
03AGT99
Ganxiaoxian (Fujian) FoodCHINA
1/20/2026
BREAD/ROLLS/BUNS, N.E.C.
03AGT99
Ganxiaoxian (Fujian) FoodCHINA
1/20/2026
BREAD/ROLLS/BUNS, N.E.C.
03AGT99
Ganxiaoxian (Fujian) FoodCHINA

Related Violations

Other violations under the same legal section: 402(a)(2)(C)(i), 801(a)(3); ADULTERATION

CodeCharge CodeCases
238UNSAFE ADD6910
2900CHLORAMP402
3440MELAMINE1

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 2966 import refusals issued for violation code 3421, affecting 697 unique firms.

When was the most recent refusal for violation 3421?

The most recent import refusal for violation 3421 was on January 21, 2026.

What products are commonly refused for violation 3421?

Products commonly refused under violation 3421 include: GOAT MILK BASED INFANT FORMULA PRODUCT (0-12 MONTHS), READY TO FEED, BREAD/ROLLS/BUNS, N.E.C., NONCARBONATED SOFT DRINK, N.E.C.. 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.