ImportRefusal LogoImportRefusal

Violation Code: 3881

FDA Violation

Charge Code: COSMETFPLA

721
Total Refusals
136
Affected Firms
12/8/2025
Latest Case
6/13/2018
First Case

Violation Details

Violation Code (ASC ID)
3881
Charge Code
COSMETFPLA
Description
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain an undeclared color additive which renders it misbranded within the meaning of Sections 1454(c)(3)(B) and 1456 of the Fair Packaging and Labeling Act.
Legal Section
1454(c)(3)(B), 1456, 801(a)(3)

Most Affected Firms

#Firm NameLocationCases
1BROW CODE PTY LTDMolendinar, AUSTRALIA192
2Unilever Lever Faberge DeutschlandMannheim, GERMANY94
3Unilever DeutschlandBuxtehude, GERMANY32
4Reckitt BenckiserUttarakhand, INDIA17
5Puig France S A SParis, FRANCE12
6Dariya CorporationNagoya, JAPAN12
7DREAM COSMETICSAbigian, IVORY COAS12
8NATURE REPUBLIC CO., LTD.Seoul, SOUTH KORE11
9QUAN TONG COSMERTICS CO.,LTDGuangzhou, CHINA10
10ORGANIC NAILSZapopan, MEXICO10
11Dey'S Medical Stores Pvt Ltd.,Kolkata, INDIA10
12Supreme Worldwide-Thane, INDIA9
13Godrej Consumer Products Ltd.Mumbai, INDIA9
14ZHEJIANG B & F COSMETICS CO LTDZhejiang, CHINA8
15Patanjali Ayurved LimitedHaridwar, INDIA8
16Hemani InternationalKarachi, PAKISTAN8
17COSMAX, INC.Hwaseong-si, SOUTH KORE7
18Karnataka Soaps & Detergents Ltd.Bangalore, INDIA7
19PATANJALI AYURVED LIMITEDHaridwar, INDIA7
20Colgate Palmolive, S.A. de C.V.Mexico City, MEXICO7

Recent Import Refusals

DateProductFirm
12/8/2025
CHILDREN NOVELTY FACE MAKEUP KITS
53GY10
Global Tone Company LimitedVIETNAM
12/8/2025
CHILDREN NOVELTY FACE MAKEUP KITS
53GY10
Global Tone Company LimitedVIETNAM
12/3/2025
BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
53JY01
Hemani InternationalPAKISTAN
12/3/2025
FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
53LY03
Himalaya Wellness CompanyINDIA
11/24/2025
HERBALS & BOTANICALS (NOT TEAS), N.E.C.
54FCY99
Patanjali Ayurved LimitedINDIA
11/21/2025
LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
53GG05
ZHEJIANG B & F COSMETICS CO LTDCHINA
11/20/2025
FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
53LD03
UL SKIN SCIENCES INCPHILIPPINE
11/20/2025
FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
53LD03
UL SKIN SCIENCES INCPHILIPPINE
11/20/2025
FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
53LD03
UL SKIN SCIENCES INCPHILIPPINE
11/20/2025
FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
53LD03
UL SKIN SCIENCES INCPHILIPPINE
11/6/2025
BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
53JY01
Karnataka Soap & Detergents LimitedINDIA
10/21/2025
OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C.
53JD99
UL SKIN SCIENCES INCPHILIPPINE
10/21/2025
OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C.
53JD99
UL SKIN SCIENCES INCPHILIPPINE
10/21/2025
HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
53EC01
Naturelle LLCUNITED ARA
10/6/2025
BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
53JY01
Wipro Ltd.INDIA

Frequently Asked Questions

What is FDA violation code 3881?

3881 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 an undeclared color additive which renders it misbranded within the meaning of Sections 1454(c)(3)(B) and 1456 of the Fair Packaging and Labeling Act.". This violation is based on 1454(c)(3)(B), 1456, 801(a)(3) of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 3881?

According to FDA Import Refusal data, there have been 721 import refusals issued for violation code 3881, affecting 136 unique firms.

When was the most recent refusal for violation 3881?

The most recent import refusal for violation 3881 was on December 8, 2025.

What products are commonly refused for violation 3881?

Products commonly refused under violation 3881 include: CHILDREN NOVELTY FACE MAKEUP KITS, BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS), FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS), HERBALS & BOTANICALS (NOT TEAS), N.E.C.. These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 3881?

Violation code 3881 is based on 1454(c)(3)(B), 1456, 801(a)(3) 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.