ImportRefusal LogoImportRefusal

Violation Code: 312

FDA Violation

Charge Code: FILTH

110
Total Refusals
62
Affected Firms
8/15/2025
Latest Case
9/13/2002
First Case

Violation Details

Violation Code (ASC ID)
312
Charge Code
FILTH
Description
The cosmetic appears to consist in whole or in part of any filthy, putrid, or decomposed substance.
Legal Section
601(b), 801(a)(3); ADULTERATION

Most Affected Firms

#Firm NameLocationCases
1Zhejiang Yasili Cosmetics Co., Ltd.Jinhua, CHINA16
2Coty Manufacturing UK Ltd.Ashford, UNITED KIN9
3Himalaya Wellness CompanyBengaluru, INDIA5
4Cosmetobellezas Natural S.A De C.V.Mexico D.F., MEXICO4
5Baja Fur S A De C VTijuana, MEXICO4
6HEIP LOIKien Giang, VIETNAM3
7Carolina AdekiyaLagos, NIGERIA3
8AYUR HERBALS PVTRAJASTHAN, INDIA3
9VIKRAM INDIA LTDRopar, INDIA2
10Delta Dis Ticaret A.S.Kasimpasa, TURKEY2
11Symrise, Inc.Teterboro, UNITED STA2
12Urbano Jimenez JuanD.F., MEXICO2
13Godrej Consumer Products Ltd.Tehsil_Nalagarh, INDIA2
14Vitry SaBignon, FRANCE2
15DajacomAccra, GHANA2
16Dabur IndiaJammu, INDIA2
17Cesar Gaona JaramilloGuayaquil, ECUADOR2
18PabBondoufle, FRANCE1
19Everglory Creations Inc.Taipei, TAIWAN1
20Color DreamsYung Kang City, TAIWAN1

Recent Import Refusals

DateProductFirm
8/15/2025
BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS)
53BD01
IPP SARLIVORY COAS
6/13/2025
SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
16XGD21
ELQUE VENTURES PRIVATE LIMITEDINDIA
2/18/2025
PEPPER, BLACK, GROUND, CRACKED (SPICE)
28BYT54
Agamahil Natural Products Private LimitedINDIA
7/8/2024
SUBTROPICAL AND TROPICAL FRUIT, DRIED OR PASTE, N.E.C.
21TGT99
Gajanand Foods Pvt LtdINDIA
3/18/2024
EYELINER (EYE MAKEUP PREPARATIONS)
53CD02
CCN SPORT HONG KONG LIMITEDHONG KONG
8/22/2023
TAMARIND, DRIED OR PASTE
21TGH14
Thuan Thien Producing Trading Limited CompanyVIETNAM
9/29/2022
MAHI MAHI
16AGT51
Propemar S.A.ECUADOR
8/18/2022
RAISINS, DRIED OR PASTE
20BGT10
A.D. InternationalINDIA
2/7/2022
COLLAGEN (COSMETIC RAW MATERIAL)
53PY02
WITHINUS NATURAL HEALTHCANADA
2/5/2020
MASCARA (EYE MAKEUP PREPARATIONS)
53CD06
VOTRE COSMETIC CO,. LTDSOUTH KORE
1/16/2020
EYE SHADOW (EYE MAKEUP PREPARATIONS)
53CY03
Everglory Creations Inc.TAIWAN
1/16/2020
EYE SHADOW (EYE MAKEUP PREPARATIONS)
53CH03
Beautydom Commodity Co. Ltd.CHINA
4/9/2018
OTHER HAIR COLORING PREPARATIONS, N.E.C.
53FD99
DEEWAL HEALTHCARE PVT LTDINDIA
4/9/2018
FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES)
53GH02
Dabur IndiaINDIA
4/9/2018
SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
53ED06
AYUR HERBALS PVTINDIA

Frequently Asked Questions

What is FDA violation code 312?

312 is an FDA violation code that indicates: "The cosmetic appears to consist in whole or in part of any filthy, putrid, or decomposed substance.". This violation is based on 601(b), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 312?

According to FDA Import Refusal data, there have been 110 import refusals issued for violation code 312, affecting 62 unique firms.

When was the most recent refusal for violation 312?

The most recent import refusal for violation 312 was on August 15, 2025.

What products are commonly refused for violation 312?

Products commonly refused under violation 312 include: BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS), SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS, PEPPER, BLACK, GROUND, CRACKED (SPICE), SUBTROPICAL AND TROPICAL FRUIT, DRIED OR PASTE, N.E.C., 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 312?

Violation code 312 is based on 601(b), 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.