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Violation Code: 310

FDA Violation

Charge Code: POISONOUS

692
Total Refusals
212
Affected Firms
11/14/2025
Latest Case
3/6/2002
First Case

Violation Details

Violation Code (ASC ID)
310
Charge Code
POISONOUS
Description
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
Legal Section
601(a), 801(a)(3); ADULTERATION

Most Affected Firms

#Firm NameLocationCases
1Zhejiang Yasili Cosmetics Co., Ltd.Jinhua, CHINA32
2Delon LaboratoriesDollard-des-Ormeaux, CANADA31
3Coty Manufacturing UK Ltd.Ashford, UNITED KIN27
4Demco Manufacturing IncSaint-Hubert, CANADA25
5Schwan Cosmetics Cr S R.O.Domoradice, CZECH REPU25
6Prosa Productos Naturales, S.A. de C.V.Mexico, MEXICO20
7Gamma Croma S.P.A.Vaiano Cremasco, ITALY17
8Shanghai Color Art Stationery Company LimitedQu Shanghai, CHINA15
9Shree Sadguru Tea AgencyNadiad, INDIA14
10Laboratoires Bio Botanical, Inc.Baie-d'Urfe, CANADA13
11Probelco S.A. de D.V.Ciudad De Mexico, MEXICO12
12Christian CosmeticosTijuana Baja Cfa, MEXICO12
13Shanghai Paristy Daily Chemical Co.Shanghai, CHINA11
14Cosmetobellezas Natural S.A De C.V.Mexico D.F., MEXICO11
15Golden MoorCasselman, CANADA10
16Zhejiang Pure Essential Cosmetic Co., Ltd.Lanxi, CHINA9
17REJUVENTUM, SA DE CVCiudad De Mexico, MEXICO9
18MEIYUME (UK) Ltd.Trowbridge, UNITED KIN9
19United Brands Marketing GmbhNiederkassel, GERMANY9
20Copolymer and Cosmetics Technology (Kunshan) Co. Ltd.Kunshan, CHINA8

Recent Import Refusals

DateProductFirm
11/14/2025
MASCARA (EYE MAKEUP PREPARATIONS)
53CD06
11/10/2025
MASCARA (EYE MAKEUP PREPARATIONS)
53CD06
10/9/2025
MASCARA (EYE MAKEUP PREPARATIONS)
53CD06
10/7/2025
MASCARA (EYE MAKEUP PREPARATIONS)
53CD06
9/17/2025
GOOSEBERRIES (BERRY)
20AGD08
9/17/2025
CARROTS AND PEAS (SWEET) (MIXED VEGETABLES)
25EGD02
9/17/2025
OKRA (FRUIT USED AS VEGETABLE)
24FGD02
9/17/2025
YAMS (ROOT & TUBER VEGETABLE)
25JGD37
4/11/2025
MOISTURIZING (SKIN CARE PREPARATIONS)
53LC06
3/4/2025
HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING)
53EA02
2/24/2025
FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES)
53GH02
9/4/2024
FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES)
53GH02
9/4/2024
FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES)
53GH02
9/4/2024
FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES)
53GH02
9/4/2024
FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES)
53GH02

Related Violations

Other violations under the same legal section: 601(a), 801(a)(3); ADULTERATION

CodeCharge CodeCases
189FLUOROCARB0

Frequently Asked Questions

What is FDA violation code 310?

310 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual. ". This violation is based on 601(a), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 310?

According to FDA Import Refusal data, there have been 692 import refusals issued for violation code 310, affecting 212 unique firms.

When was the most recent refusal for violation 310?

The most recent import refusal for violation 310 was on November 14, 2025.

What products are commonly refused for violation 310?

Products commonly refused under violation 310 include: MASCARA (EYE MAKEUP PREPARATIONS), GOOSEBERRIES (BERRY). These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 310?

Violation code 310 is based on 601(a), 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.