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Violation Code: 3020

FDA Violation

Charge Code: STARANISE

3
Total Refusals
2
Affected Firms
8/15/2014
Latest Case
1/13/2011
First Case

Violation Details

Violation Code (ASC ID)
3020
Charge Code
STARANISE
Description
The article appears to bear or contain a food additive, Japanese star anise, that is unsafe within the meaning of section 409.
Legal Section
402(a)(2)(C)(i), 801(a)(3), Adulteration

Most Affected Firms

#Firm NameLocationCases
1Eswaran Brothers Exports (PVT) LtdColombo 14, SRI LANKA2
2Herbots Animal Products SprlHalle-Booienhoven, BELGIUM1

Recent Import Refusals

DateProductFirm
8/15/2014
EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
66YBY99
8/15/2014
EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
66YBY99
1/13/2011
VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
54YMT99

Frequently Asked Questions

What is FDA violation code 3020?

3020 is an FDA violation code that indicates: "The article appears to bear or contain a food additive, Japanese star anise, that is unsafe within the meaning of section 409.". This violation is based on 402(a)(2)(C)(i), 801(a)(3), Adulteration of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 3020?

According to FDA Import Refusal data, there have been 3 import refusals issued for violation code 3020, affecting 2 unique firms.

When was the most recent refusal for violation 3020?

The most recent import refusal for violation 3020 was on August 15, 2014.

What products are commonly refused for violation 3020?

Products commonly refused under violation 3020 include: EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C., VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.. These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 3020?

Violation code 3020 is based on 402(a)(2)(C)(i), 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.