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Violation Code: 254

FDA Violation

Charge Code: STD QUALIT

109
Total Refusals
62
Affected Firms
9/11/2025
Latest Case
6/12/2002
First Case

Violation Details

Violation Code (ASC ID)
254
Charge Code
STD QUALIT
Description
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(h)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a standard of quality has been prescribed by regulation as provided by Section 401 of the FD&C Act, and its quality falls below such standard and its label does not bear a statement that it falls below such standard in such manner and form as such regulations specify.
Legal Section
403(h)(1), 801(a)(3); MISBRANDING

Most Affected Firms

#Firm NameLocationCases
1Fabrica de Galletas La Moderna S.A. de C.V.Toluca De Lerdo, MEXICO9
2Tibet Ithalat Ihracat Ve Kozmetik Sanayi A.S.Pendik, TURKEY7
3BAHIA MARES DEL PACIFICO SASBuenaventura, COLOMBIA6
4Petfoodnz InternationalGisborne, NEW ZEALAN6
5NC MACARON COMPAlley, IRAN3
6KITCHEN XPRESS OVERSEAS LTDGujarat, INDIA3
7Conex S.A.Athens, GREECE3
8DONG YANG FOOD CO.Seoul, SOUTH KORE3
9Rakza Mohammed Conditionnement & Exportation Dea ProduitsagrBou Saada, ALGERIA3
10MASRODAN FOR EXPORT AND IMPORTCairo, EGYPT3
11GUANGXI JIABAO FROZEN FOODS CO.LTD.Hezhou, CHINA2
12Productos Alimenticios La Moderna S.A. De C.V.Toluca De Lerdo, MEXICO2
13Molinera de Mexico S.A. de C.V.Naucalpan De Juarez, MEXICO2
14ANGAGA MARKET SA DE CVHermosillo, MEXICO2
15Ceres Friut Juices (Pty) LtdPaarl, SOUTH AFRI2
16Mehadrin Tnuport Export L.P. Prior Ashkelon Packing HouseBeerot Yitzhak, ISRAEL2
17Andes Quality S.A.Santiago, CHILE2
18TAJ FOOD (PVT LTD)Murdike, PAKISTAN2
19Nestle De Mexico Sa De CvD.F., MEXICO2
20Lankan DelightGampaha District, SRI LANKA2

Recent Import Refusals

DateProductFirm
9/11/2025
MIXED PLAIN COOKIES,BISCUITS AND WAFERS
03HGT07
9/10/2025
BUTTER/BUTTER FLAVORED,PLAIN COOKIES,BISCUITS AND WAFERS
03HGT08
9/10/2025
MIXED FILLED/ICED COOKIES,BISCUITS AND WAFERS
03JGT07
9/10/2025
VANILLA PLAIN COOKIE,BISCUIT AND WAFER
03HGT01
9/10/2025
MIXED FILLED/ICED COOKIES,BISCUITS AND WAFERS
03JGT07
9/3/2025
MIXED PLAIN COOKIES,BISCUITS AND WAFERS
03HGT07
9/3/2025
BUTTER/BUTTER FLAVORED,PLAIN COOKIES,BISCUITS AND WAFERS
03HGT08
9/3/2025
BUTTER/BUTTER FLAVORED,PLAIN COOKIES,BISCUITS AND WAFERS
03HGT08
9/3/2025
BUTTER/BUTTER FLAVORED,PLAIN COOKIES,BISCUITS AND WAFERS
03HGT08
7/22/2025
MACARONI AND SPAGHETTI PRODUCTS,N.E.C.
04AGT99
5/7/2025
SUGAR PRODUCTS, N.E.C.
36AYT99
12/31/2024
CREAM, SOUR
09CGT12
12/31/2024
CHEESE, HARD (CHESIRE,ESRUM,FORTINA,FORTINE,KASSENI,MOZZARELLA,MONTASIO,PECARINO,PORT SALUT, ETC)
12AGT19
10/9/2024
CRAB
16JGC01
10/9/2024
CRAB
16JGC01

Frequently Asked Questions

What is FDA violation code 254?

254 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(h)(1) of the FD&C Act in that the article purports to be or is represented as a food for which a standard of quality has been prescribed by regulation as provided by Section 401 of the FD&C Act, and its quality falls below such standard and its label does not bear a statement that it falls below such standard in such manner and form as such regulations specify. ". This violation is based on 403(h)(1), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 254?

According to FDA Import Refusal data, there have been 109 import refusals issued for violation code 254, affecting 62 unique firms.

When was the most recent refusal for violation 254?

The most recent import refusal for violation 254 was on September 11, 2025.

What products are commonly refused for violation 254?

Products commonly refused under violation 254 include: MIXED PLAIN COOKIES,BISCUITS AND WAFERS, BUTTER/BUTTER FLAVORED,PLAIN COOKIES,BISCUITS AND WAFERS, MIXED FILLED/ICED COOKIES,BISCUITS AND WAFERS, VANILLA PLAIN COOKIE,BISCUIT AND WAFER. These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 254?

Violation code 254 is based on 403(h)(1), 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.