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Violation Code: 295

FDA Violation

Charge Code: LISTERIA

3,187
Total Refusals
748
Affected Firms
12/31/2025
Latest Case
10/3/2001
First Case

Violation Details

Violation Code (ASC ID)
295
Charge Code
LISTERIA
Description
The article is subject to refusal of admission pursuant to Section 801(a)(3), in that the article appears to contain Listeria monocytogenes, a poisonous and deleterious substance, which may render it injurious to health.
Legal Section
402(a)(1), 801(a)(3); ADULTERATION

Most Affected Firms

#Firm NameLocationCases
1Flor De Baja S A De C VMexicali, MEXICO151
2QL FOODS SDN. BHD.Hutan Melintang, MALAYSIA108
3Olympic Eel & Salmon Industries SAPreveza, GREECE57
4Yancheng Hi-King Agriculture Developing Co., Ltd.Yancheng, CHINA45
5Thomas Bagnac ExportThiais, FRANCE40
6PT Bumi Menara InternusaSurabaya, INDONESIA38
7AJIRUSHI CO., LTD. - Main PlantHitachinaka, JAPAN37
8Fromages.comTours, FRANCE35
9Foppen Paling En Zalm B.V.Harderwijk, NETHERLAND34
10A & L Seafoods LtdLouisbourg, CANADA31
11PRODUCTOS MAYATIJUANA, MEXICO29
12Fromagerie BeillevaireMachecoul St Meme, FRANCE29
13St James Luxury Smoked Foods (Scotland) LtdWigtownshire, UNITED KIN27
14DexpaThiais, FRANCE27
15Hee Chang Trading Company LTDSeo, SOUTH KORE26
16Premium Seafood Sp. z o.o.Darlowo, POLAND26
17St. James Smokehouse (Scotland) Ltd.Annan, UNITED KIN25
18FROMI RUNGIS SASRungis, FRANCE25
19PLASSE SAJassans Riottier, FRANCE24
20Perrin-Vermot SACleron, FRANCE23

Recent Import Refusals

DateProductFirm
12/31/2025
MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.
25PGY99
12/23/2025
ENOKITAKE MUSHROOMS, WHOLE (BUTTON) (FUNGI)
25PGC11
12/23/2025
ENOKITAKE
25SGC14
12/17/2025
ENOKITAKE MUSHROOMS, WHOLE (BUTTON) (FUNGI)
25PGC11
12/16/2025
SOFT RIPENED CHEESE MADE FROM COW'S MILK (E.G., BRIE, CAMEMBERT)
12AJO56
12/16/2025
MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.
25PGC99
12/15/2025
ENOKITAKE
25SGT14
12/15/2025
ENOKITAKE
25SGT14
12/15/2025
MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.
25PGC99
12/15/2025
FUNGUS, WHITE, WHOLE (BUTTON) (FUNGI)
25PGC10
12/13/2025
MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.
25PGC99
12/11/2025
ENOKITAKE MUSHROOMS, WHOLE (BUTTON) (FUNGI)
25PGT11
11/25/2025
SOFT RIPENED CHEESE MADE FROM COW'S MILK (E.G., BRIE, CAMEMBERT)
12AJO56
11/19/2025
ENOKITAKE MUSHROOMS, WHOLE (BUTTON) (FUNGI)
25PYC11
11/19/2025
ENOKITAKE MUSHROOMS, WHOLE (BUTTON) (FUNGI)
25PYC11

Related Violations

Other violations under the same legal section: 402(a)(1), 801(a)(3); ADULTERATION

CodeCharge CodeCases
9SALMONELLA23378
251POISONOUS4971
297AFLATOXIN729
281BACTERIA483
3878POISONORD374
245EXCESS SUL142
3897MYCOTOXIN54
3460VIBRIO49

Frequently Asked Questions

What is FDA violation code 295?

295 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3), in that the article appears to contain Listeria monocytogenes, a poisonous and deleterious substance, which may render it injurious to health.". This violation is based on 402(a)(1), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 295?

According to FDA Import Refusal data, there have been 3187 import refusals issued for violation code 295, affecting 748 unique firms.

When was the most recent refusal for violation 295?

The most recent import refusal for violation 295 was on December 31, 2025.

What products are commonly refused for violation 295?

Products commonly refused under violation 295 include: MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C., ENOKITAKE MUSHROOMS, WHOLE (BUTTON) (FUNGI), ENOKITAKE, SOFT RIPENED CHEESE MADE FROM COW'S MILK (E.G., BRIE, CAMEMBERT). These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 295?

Violation code 295 is based on 402(a)(1), 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.