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Violation Code: 482

FDA Violation

Charge Code: NUTRIT LBL

35,628
Total Refusals
10303
Affected Firms
12/31/2025
Latest Case
10/1/2001
First Case

Violation Details

Violation Code (ASC ID)
482
Charge Code
NUTRIT LBL
Description
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Legal Section
403(q); 801(a)(3); Misbranding

Most Affected Firms

#Firm NameLocationCases
1Cadbury Trebor BassettBirmingham, UNITED KIN631
2COMERCIALIZADORA PEPSICOCiudad De Mexico, MEXICO295
3Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)Tlajomulco De Zuniga, MEXICO220
4Nestle Food ServiceYork, UNITED KIN208
5Comercializadora Pepsico Mexico,Ciudad De Mexico, MEXICO158
6H J Heinz Co LtdHayes, UNITED KIN155
7Nutri-Asia, Incorporated dba UFC PhilippinesLaguna, PHILIPPINE133
8Mars Confectionery Div Of Mars UK LtdSlough, UNITED KIN115
9Burton Foods LimitedBlackpool, UNITED KIN114
10Nestle India LimitedBicholim, INDIA108
11Alnost Guatemala S.AGuatemala, GUATEMALA83
12NisaWay / Bibby DistributionScunthorpe, UNITED KIN80
13Oliver Olives, Inc.Bolton, CANADA79
14Qwaider Packing & Trading EstAmman, JORDAN79
15UL Costa Rica SCC, S.A.Heredia, COSTA RICA78
16Fresh Hemp Foods, Ltd.Winnipeg, CANADA77
17Batleys plcSalford, UNITED KIN77
18Nisa InternationalGrimsby, UNITED KIN73
19Rochef ChocolatierGatineau, CANADA70
20PHARMA GREEN S.R.L.Falciano, ITALY70

Recent Import Refusals

DateProductFirm
12/31/2025
MILK BREAD/ROLLS/BUNS
03AGT08
12/31/2025
COFFEE, INSTANT
31AGT03
12/30/2025
CORN CHIPS, FRIED
07BGT02
12/29/2025
BANANA SAUCE
37JCT13
12/29/2025
BANANA SAUCE
37JCT13
12/29/2025
BANANA SAUCE
37JCE13
Nutri-AsiaPHILIPPINE
12/23/2025
MACAROON,PREPARED DRY COOKIE, BISCUITS AND WAFER MIXES WITH MILK OR EGGS
03KYH11
12/23/2025
CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
33SYY99
12/23/2025
CAKE DOUGH OR BATTER WITHOUT CUSTARD OR CREAM FILLING
03TYY01
12/23/2025
CAKE DOUGH OR BATTER WITHOUT CUSTARD OR CREAM FILLING
03TYY01
12/23/2025
CAKE DOUGH OR BATTER WITHOUT CUSTARD OR CREAM FILLING
03TYY01
12/23/2025
KIWANO MELON (ENGLISH TOMATO)
22BYH08
12/23/2025
KIWI FRUIT, DRIED OR PASTE
21TYH11
12/23/2025
MARSHMALLOW CANDY, HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
33EYH09
12/23/2025
OTHER FRUIT AND FRUIT PRODUCTS, DRIED AND PASTE, N.E.C.
22HYH99

Frequently Asked Questions

What is FDA violation code 482?

482 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 misbranded in that the label or labeling fails to bear the required nutrition information.". This violation is based on 403(q); 801(a)(3); Misbranding of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 482?

According to FDA Import Refusal data, there have been 35628 import refusals issued for violation code 482, affecting 10303 unique firms.

When was the most recent refusal for violation 482?

The most recent import refusal for violation 482 was on December 31, 2025.

What products are commonly refused for violation 482?

Products commonly refused under violation 482 include: MILK BREAD/ROLLS/BUNS, COFFEE, INSTANT, CORN CHIPS, FRIED, BANANA SAUCE. These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 482?

Violation code 482 is based on 403(q); 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.