ImportRefusal LogoImportRefusal

Violation Code: 2981

FDA Violation

Charge Code: BIO TOXIN

16
Total Refusals
9
Affected Firms
7/25/2022
Latest Case
11/18/2004
First Case

Violation Details

Violation Code (ASC ID)
2981
Charge Code
BIO TOXIN
Description
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous and deleterious substance which would ordinarily render it injurious to health. Appears to contain
Legal Section
402(a)(1), 801(a)(3), Adulteration

Most Affected Firms

Recent Import Refusals

DateProductFirm
7/25/2022
ASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS)
54FYY94
7/25/2022
ASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS)
54FYY94
7/25/2022
ASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS)
54FYY94
7/25/2022
ASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS)
54FCY94
7/25/2022
ASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS)
54FCY94
7/25/2022
ASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS)
54FCY94
8/20/2015
COMB PROD PET CAT FOOD
72AHE05
1/30/2013
HERBALS & BOTANICALS (NOT TEAS), N.E.C.
54FBT99
1/30/2013
HERBALS & BOTANICALS (NOT TEAS), N.E.C.
54FBT99
3/30/2011
HERBALS & BOTANICAL TEAS, N.E.C.
54EBT99
4/16/2009
HERBALS & BOTANICAL TEAS, N.E.C.
54EBY99
4/16/2009
ARISTOLOCHIA (FANGCHI), (HERBAL & BOTANICALS, NOT TEA)
54FBY31
6/6/2006
PUFFER
16AFC65
2/6/2006
PUFFER
16AGT65
2/23/2005
OTHER FRAGRANCE PREPARATIONS, N.E.C.
53DY99

Related Violations

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

CodeCharge CodeCases
2080COUMARIN68
3420MELAMINE1

Frequently Asked Questions

What is FDA violation code 2981?

2981 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 contain a poisonous and deleterious substance which would ordinarily render it injurious to health. Appears to contain". 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 2981?

According to FDA Import Refusal data, there have been 16 import refusals issued for violation code 2981, affecting 9 unique firms.

When was the most recent refusal for violation 2981?

The most recent import refusal for violation 2981 was on July 25, 2022.

What products are commonly refused for violation 2981?

Products commonly refused under violation 2981 include: ASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS). These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 2981?

Violation code 2981 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.