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Violation Code: 2360

FDA Violation

Charge Code: HISTAMINE

1,084
Total Refusals
276
Affected Firms
10/24/2025
Latest Case
10/1/2001
First Case

Violation Details

Violation Code (ASC ID)
2360
Charge Code
HISTAMINE
Description
The article appears to bear or contain histamine, a poisonous and deleterious substance in such quantity as ordinarily renders it injurious to health.
Legal Section
402(a)(1), 801(a)(3); Adulteration

Most Affected Firms

#Firm NameLocationCases
1SOCIETE DE CONSERVERIE EN AFRIQUE (SCA S.A.)Dakar, SENEGAL110
2Hai Vuong Co., Ltd.Cam Lam District, VIETNAM70
3Southeast Asian Packaging and Canning Limited.Mueang Samut Prakan, THAILAND24
4PT Dharma Samudera Fishing Industries TBKJakarta, INDONESIA22
5PT. Winson Prima SejahteraMedan, INDONESIA21
6PESCAMOZ LDABeira, MOZAMBIQUE21
7Thai Ocean Venture CompanyMueang Phuket, THAILAND20
8Mendoza IndustriesDipolog City, PHILIPPINE17
9Pt. Kelola Mina Laut- Integrated Seafood IndustriesGresik, INDONESIA16
10Hochico Marine Processing Corp.Yilan County, TAIWAN15
11GGC TWN. Co., Ltd.Amphur Mueang Phuket, THAILAND15
12Binh Dinh Fishery Joint Stock CompanyQuy Nhon, VIETNAM13
13Ky Lan Seafood Processing Joint Stock CompanyPhan Theit City, VIETNAM13
14Tin Thinh Co., Ltd.Nha Trang City, VIETNAM12
15PT. Chen Woo FisheryMakassar, INDONESIA12
16GRUPO DEGFER CIA LTDAManta, ECUADOR12
17Huang Chi Frozen Food Factory Co., Ltd.Kaohsiung, TAIWAN11
18Southeast Asian Packaging And Canning Ltd.Muang, THAILAND11
19P.T. BonecomJakarta, INDONESIA11
20Propemar S.A.Montecristi, ECUADOR11

Recent Import Refusals

DateProductFirm
10/24/2025
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVE45
10/16/2025
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVE45
10/16/2025
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVE45
10/16/2025
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVE45
10/16/2025
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVE45
10/16/2025
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVE45
10/16/2025
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVE45
10/2/2025
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVE45
10/2/2025
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVE45
10/2/2025
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVE45
10/1/2025
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVE45
10/1/2025
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVE45
10/1/2025
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVE45
10/1/2025
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVE45
10/1/2025
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVE45

Frequently Asked Questions

What is FDA violation code 2360?

2360 is an FDA violation code that indicates: "The article appears to bear or contain histamine, a poisonous and deleterious substance in such quantity as ordinarily renders 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 2360?

According to FDA Import Refusal data, there have been 1084 import refusals issued for violation code 2360, affecting 276 unique firms.

When was the most recent refusal for violation 2360?

The most recent import refusal for violation 2360 was on October 24, 2025.

What products are commonly refused for violation 2360?

Products commonly refused under violation 2360 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 2360?

Violation code 2360 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.