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Violation Code: 3180

FDA Violation

Charge Code: PATULIN

14
Total Refusals
7
Affected Firms
1/8/2021
Latest Case
12/27/2005
First Case

Violation Details

Violation Code (ASC ID)
3180
Charge Code
PATULIN
Description
The article is subject to refusal of admission pursuant to Section 801(a) (3) of the Act, in that it appears to contain Patulin, 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
1Natural Agri S.R.L.Neuquen, ARGENTINA5
2JUGOS LUGA S.A.Mainque, ARGENTINA3
3Golden Town Apple Products LtdThornbury, CANADA2
4Zumos Argentinos S.A.Cinco Saltos, ARGENTINA1
5Huertas de la Empacadora S de PR de RLGuerrero, MEXICO1
6Apple Valley Juice CorporationClarksburg, CANADA1
7Sunraysia Five Star (Global)South Melbourne, AUSTRALIA1

Recent Import Refusals

DateProductFirm
1/8/2021
APPLE, CORE FRUIT JUICES OR CONCENTRATES
20SGF01
1/8/2021
APPLE, CORE FRUIT JUICES OR CONCENTRATES
20SGF01
10/23/2017
APPLE, CORE FRUIT JUICES OR CONCENTRATES
20SCO01
5/27/2014
APPLE, CORE FRUIT JUICES OR CONCENTRATES
20SJT01
1/23/2012
APPLE, CORE FRUIT JUICES OR CONCENTRATES
20SEO01
11/29/2007
APPLE, CORE FRUIT JUICES OR CONCENTRATES
20SHO01
3/26/2007
APPLE, CORE FRUIT JUICES OR CONCENTRATES
20SHO01
8/14/2006
APPLE, CORE FRUIT JUICES OR CONCENTRATES
20SJD01
8/14/2006
APPLE, CORE FRUIT JUICES OR CONCENTRATES
20SJD01
8/14/2006
APPLE, CORE FRUIT JUICES OR CONCENTRATES
20SJD01
8/14/2006
APPLE, CORE FRUIT JUICES OR CONCENTRATES
20SJD01
2/10/2006
APPLE, CORE FRUIT JUICES OR CONCENTRATES
20SET01
1/10/2006
APPLE, CORE FRUIT JUICES OR CONCENTRATES
20SET01
12/27/2005
APPLE, CORE FRUIT JUICES OR CONCENTRATES
20SGT01

Related Violations

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

CodeCharge CodeCases
9SALMONELLA23378
251POISONOUS4971
295LISTERIA3187
297AFLATOXIN729
281BACTERIA483
3878POISONORD374
245EXCESS SUL142
3897MYCOTOXIN54

Frequently Asked Questions

What is FDA violation code 3180?

3180 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a) (3) of the Act, in that it appears to contain Patulin, 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 3180?

According to FDA Import Refusal data, there have been 14 import refusals issued for violation code 3180, affecting 7 unique firms.

When was the most recent refusal for violation 3180?

The most recent import refusal for violation 3180 was on January 8, 2021.

What products are commonly refused for violation 3180?

Products commonly refused under violation 3180 include: APPLE, CORE FRUIT JUICES OR CONCENTRATES. These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 3180?

Violation code 3180 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.