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Violation Code: 3200

FDA Violation

Charge Code: COSM MISB2

128
Total Refusals
72
Affected Firms
12/15/2025
Latest Case
8/8/2005
First Case

Violation Details

Violation Code (ASC ID)
3200
Charge Code
COSM MISB2
Description
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that its labeling is false or misleading in any particular.
Legal Section
602(a) & 801(a)(3); MISBRANDING

Most Affected Firms

#Firm NameLocationCases
1Reckitt BenckiserUttarakhand, INDIA13
2Unilever Lever Faberge DeutschlandMannheim, GERMANY8
3PATANJALI AYURVED LIMITEDHaridwar, INDIA7
4DREAM COSMETICSAbigian, IVORY COAS5
5YIWU LINKBEAUTY BIOTECHNOLOGY COLTDJinhua, CHINA4
6Unilever Philippines, Inc. - Cavite FactoryCalabarzon, PHILIPPINE3
7Unilever DeutschlandBuxtehude, GERMANY3
8WIPRO LTD.Ahobala Agrahara, INDIA3
9KEO KARPIN PVT LTDKolkata, INDIA3
10ZHEJIANG B & F COSMETICS CO LTDZhejiang, CHINA3
11DION ENTERPRISE CO LTDMae Sot Tay, THAILAND3
12Puig France S A SParis, FRANCE3
13Wipro Ltd.Haridwar, INDIA2
14Radhey Shyam and sonsDelhi, INDIA2
15O-SOD HERBAL COBangkok, THAILAND2
16MARGO COSMETICSCracow, POLAND2
17Casmara Cosmetics, S.A.Paterna, SPAIN2
18GUANGZHOU MEIKUANG COSMETICS COLTDGuangzhou, CHINA2
19Dabur India LimitedSilvassa, INDIA2
20Ida Laboratories Co., Ltd.Tokyo, JAPAN2

Recent Import Refusals

DateProductFirm
12/15/2025
FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
53LC03
SHENZHEN GENENG CLEANING EQUIPMENT CO., LTDCHINA
10/24/2025
SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
53EY06
Onesto Labs Private LimitedINDIA
8/7/2025
EYE SHADOW (EYE MAKEUP PREPARATIONS)
53CH03
YIWU LINKBEAUTY BIOTECHNOLOGY COLTDCHINA
8/7/2025
EYE SHADOW (EYE MAKEUP PREPARATIONS)
53CH03
YIWU LINKBEAUTY BIOTECHNOLOGY COLTDCHINA
8/6/2025
EYE SHADOW (EYE MAKEUP PREPARATIONS)
53CH03
YIWU LINKBEAUTY BIOTECHNOLOGY COLTDCHINA
8/6/2025
EYE SHADOW (EYE MAKEUP PREPARATIONS)
53CH03
YIWU LINKBEAUTY BIOTECHNOLOGY COLTDCHINA
6/30/2025
BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
53JK01
Reckitt BenckiserINDIA
6/30/2025
BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
53JK01
Karnataka Soap & Detergents LimitedINDIA
6/30/2025
BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
53JK01
Cholayil PVT LTDINDIA
6/30/2025
BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
53JK01
PATANJALI AYURVED LIMITEDINDIA
6/30/2025
BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
53JK01
PATANJALI AYURVED LIMITEDINDIA
6/30/2025
BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
53JK01
PATANJALI AYURVED LIMITEDINDIA
4/17/2025
SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
53EY06
HINDUSTAN UNILEVER LTDINDIA
4/2/2025
EYE SHADOW (EYE MAKEUP PREPARATIONS)
53CH03
GUANGZHOU MEIKUANG COSMETICS COLTDCHINA
4/2/2025
EYE SHADOW (EYE MAKEUP PREPARATIONS)
53CH03
GUANGZHOU MEIKUANG COSMETICS COLTDCHINA

Related Violations

Other violations under the same legal section: 602(a) & 801(a)(3); MISBRANDING

CodeCharge CodeCases
2940COSM MISB76

Frequently Asked Questions

What is FDA violation code 3200?

3200 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 that its labeling is false or misleading in any particular.". This violation is based on 602(a) & 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 3200?

According to FDA Import Refusal data, there have been 128 import refusals issued for violation code 3200, affecting 72 unique firms.

When was the most recent refusal for violation 3200?

The most recent import refusal for violation 3200 was on December 15, 2025.

What products are commonly refused for violation 3200?

Products commonly refused under violation 3200 include: FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS), SHAMPOOS (HAIR PREPARATIONS, NON-COLORING), EYE SHADOW (EYE MAKEUP PREPARATIONS). These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 3200?

Violation code 3200 is based on 602(a) & 801(a)(3); MISBRANDING 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.