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Violation Code: 48

FDA Violation

Charge Code: NEEDS ACID

451
Total Refusals
139
Affected Firms
11/13/2025
Latest Case
11/2/2001
First Case

Violation Details

Violation Code (ASC ID)
48
Charge Code
NEEDS ACID
Description
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health due to inadequate acidification.
Legal Section
402(a)(4), 801(a)(3); ADULTERATION

Most Affected Firms

#Firm NameLocationCases
1Ciemme Alimentari S.r.l.Barletta, ITALY73
2Global Food Solutions, IncorporatedSan Pablo, PHILIPPINE37
3N.a. Food Products Co.,ltdNakhon Pathom, THAILAND31
4A Tremoceira Estela da Piedade LdaCharneca da Caparica, PORTUGAL25
5SICHUAN BAIJIA FOOD INDUSTRIAL CO.,LTDSichuan, CHINA19
6Saesao Intertrade Ltd., Part.Phibun Mangsahan, THAILAND10
7HAITAI BEVERAGE ANSUNG FACTORYANSUNG CITY, SOUTH KORE8
8Provitus Dabrowscy ,Malesa S.J.Zambrow, POLAND8
9Charlie Brown di Rutigliano & Figli S.r.l.Binetto, ITALY8
10Hung Loi Manufacturing and Trading Co. Ltd.Ho Chi Minh City, VIETNAM8
11SOCIETE DE CONSERVERIE EN AFRIQUE (SCA S.A.)Dakar, SENEGAL8
12Daedong Korea Ginseng Co., Ltd.Geumsan-gun, SOUTH KORE7
13NAMPRIK MAE-ANONG CO., LTD.Bangkok, THAILAND7
14ARKO FOODS PHILS, INC.Valenzuela, PHILIPPINE7
15Good Morning Seoul Corp.Tongduchon, SOUTH KORE6
16Boscovivo s.n.c.Civitella In Val Di Chiana, ITALY6
17DervalDerval, FRANCE5
18GOOD DAY FOODS LTDTHANE (W), INDIA4
19Dulces Regionales Tres Reyes S.A. de C.V.Zamora, MEXICO4
20Chang Tuh Family CorporationKimpo City, SOUTH KORE4

Recent Import Refusals

DateProductFirm
11/13/2025
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVE45
11/13/2025
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVE45
11/13/2025
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVE45
11/13/2025
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVE45
11/13/2025
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVE45
11/13/2025
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVE45
11/13/2025
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVE45
11/13/2025
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVE45
10/29/2025
JALAPENO PEPPER, HOT, DRIED OR PASTE
24HGI12
10/21/2025
TEA, OOLONG
31KGT03
10/21/2025
TEA, OOLONG
31KGT03
7/17/2025
CUCUMBERS (FRUIT USED AS VEGETABLE)
24FCI20
6/30/2025
MANGO (SUBTROPICAL AND TROPICAL FRUIT)
21SCP05
6/26/2025
MANGO (SUBTROPICAL AND TROPICAL FRUIT)
21SGI05
5/21/2025
MANGO (SUBTROPICAL AND TROPICAL FRUIT)
21SCP05

Related Violations

Other violations under the same legal section: 402(a)(4), 801(a)(3); ADULTERATION

CodeCharge CodeCases
83NO PROCESS21145
62NEEDS FCE13735
306INSANITARY4036
181UNDER PRC814
3898INADPRCCTL273
3161NONRSP-PRC74
152SOAKED/WET73
3240NOCONTCODE53

Frequently Asked Questions

What is FDA violation code 48?

48 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 have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health due to inadequate acidification.". This violation is based on 402(a)(4), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 48?

According to FDA Import Refusal data, there have been 451 import refusals issued for violation code 48, affecting 139 unique firms.

When was the most recent refusal for violation 48?

The most recent import refusal for violation 48 was on November 13, 2025.

What products are commonly refused for violation 48?

Products commonly refused under violation 48 include: TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.). These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 48?

Violation code 48 is based on 402(a)(4), 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.