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Violation Code: 314

FDA Violation

Charge Code: CONTAINER

15
Total Refusals
12
Affected Firms
11/29/2019
Latest Case
1/18/2002
First Case

Violation Details

Violation Code (ASC ID)
314
Charge Code
CONTAINER
Description
The container appears to be composed, in whole or in part, of a poisonous or deleterious substance which may render the contents injurious to health.
Legal Section
601(d), 801(a)(3); ADULTERATION

Most Affected Firms

#Firm NameLocationCases
1Ets Diana De BeauteBeyrouth, LEBANON3
2CHINA SKU CO., LTDYiwu, CHINA2
3Colgate Palmolive CompanySalford Manchester, UNITED KIN1
4Davines S.p.A.Parma, ITALY1
5WHITMAN LABORATORIES LTD.Petersfield, UNITED KIN1
6Demco Manufacturing IncSaint-Hubert, CANADA1
7TAIBA DATES TRADING ESTABLISHMENTJeddah, SAUDI ARAB1
8Hue LeeVientiana, LAOS1
9Hatimi AgencyMumbia, INDIA1
10Coty Manufacturing UK Ltd.Ashford, UNITED KIN1
11SAEED GHANI PVT.,LTDKarachi, PAKISTAN1
12Intergraze AbVastra Frolunda, SWEDEN1

Recent Import Refusals

DateProductFirm
11/29/2019
FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
53LY03
7/19/2017
EYE SHADOW (EYE MAKEUP PREPARATIONS)
53CY03
7/19/2017
EYE SHADOW (EYE MAKEUP PREPARATIONS)
53CY03
3/20/2017
HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING)
53EA02
10/4/2012
EYELINER (EYE MAKEUP PREPARATIONS)
53CK02
10/4/2012
EYE SHADOW (EYE MAKEUP PREPARATIONS)
53CK03
7/17/2012
OTHER SKIN CARE PREPARATIONS, N.E.C.
53LY99
7/17/2012
OTHER SKIN CARE PREPARATIONS, N.E.C.
53LY99
7/17/2012
OTHER SKIN CARE PREPARATIONS, N.E.C.
53LY99
12/23/2010
CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
53LJ01
9/18/2007
EYE SHADOW (EYE MAKEUP PREPARATIONS)
53CH03
8/8/2007
FACE MAKEUP KITS (MAKEUP PREPARATIONS, NOT FOR EYES)
53GD09
4/30/2002
HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING)
53EA02
2/27/2002
HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING)
53EA02
1/18/2002
HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING)
53EA02

Frequently Asked Questions

What is FDA violation code 314?

314 is an FDA violation code that indicates: "The container appears to be composed, in whole or in part, of a poisonous or deleterious substance which may render the contents injurious to health.". This violation is based on 601(d), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 314?

According to FDA Import Refusal data, there have been 15 import refusals issued for violation code 314, affecting 12 unique firms.

When was the most recent refusal for violation 314?

The most recent import refusal for violation 314 was on November 29, 2019.

What products are commonly refused for violation 314?

Products commonly refused under violation 314 include: FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS), EYE SHADOW (EYE MAKEUP PREPARATIONS), HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING), EYELINER (EYE MAKEUP PREPARATIONS). These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 314?

Violation code 314 is based on 601(d), 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.