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Violation Code: 3040

FDA Violation

Charge Code: HEPATITISA

48
Total Refusals
6
Affected Firms
12/11/2019
Latest Case
8/16/2006
First Case

Violation Details

Violation Code (ASC ID)
3040
Charge Code
HEPATITISA
Description
The article is subject to refusal of admission to pursuant Section 801(a)(3) in that it appears to contain Hepatitis A Virus, a poisonous or deleterious substance which may render it injurious to health.
Legal Section
Section 801(a)(3), 402(a)(1); ADULTERATION

Most Affected Firms

#Firm NameLocationCases
1Sustainable Seafood Co., Ltd.Cam Lam, VIETNAM33
2PT. Deho Canning CompanyBitung, INDONESIA7
3Agricola La Laguna, S.A. De C.V.Ensenanda, MEXICO3
4Sun Fresh S.A. De C.V.Ensenada, MEXICO3
5ARTURO MANUEL ROMANDIA TOYOSGuaymas, MEXICO1
6Hibrid D.O.O.Gornja Dobrinja, SERBIA1

Recent Import Refusals

DateProductFirm
12/11/2019
RASPBERRIES, RED (BERRY)
20AGD13
1/22/2019
CRAB
16JGC01
5/31/2018
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AGD45
5/31/2018
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AGD45
5/31/2018
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AGD45
5/31/2018
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AGD45
5/31/2018
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AGD45
5/31/2018
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AGD45
5/31/2018
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AGD45
3/9/2018
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVD45
3/9/2018
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVD45
3/9/2018
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVD45
3/9/2018
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVD45
3/9/2018
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AVD45
3/9/2018
TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
16AGD45

Frequently Asked Questions

What is FDA violation code 3040?

3040 is an FDA violation code that indicates: "The article is subject to refusal of admission to pursuant Section 801(a)(3) in that it appears to contain Hepatitis A Virus, a poisonous or deleterious substance which may render it injurious to health.". This violation is based on Section 801(a)(3), 402(a)(1); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 3040?

According to FDA Import Refusal data, there have been 48 import refusals issued for violation code 3040, affecting 6 unique firms.

When was the most recent refusal for violation 3040?

The most recent import refusal for violation 3040 was on December 11, 2019.

What products are commonly refused for violation 3040?

Products commonly refused under violation 3040 include: RASPBERRIES, RED (BERRY), CRAB, 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 3040?

Violation code 3040 is based on Section 801(a)(3), 402(a)(1); 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.