ImportRefusal LogoImportRefusal

Violation Code: 73

FDA Violation

Charge Code: DRUG COLOR

44
Total Refusals
29
Affected Firms
10/31/2025
Latest Case
12/18/2001
First Case

Violation Details

Violation Code (ASC ID)
73
Charge Code
DRUG COLOR
Description
The article appears to be a color additive the intended use of which is for the purpose of coloring only, and its packaging and labeling do not conform to regulations issued under section 721.
Legal Section
502(m), 801(a)(3); MISBRANDING

Most Affected Firms

#Firm NameLocationCases
1Nouvelle Parfumeria GandourAbidjan 01, IVORY COAS7
2Johnson & Johnson Gmbh LtdMaidenhead, UNITED KIN3
3Emami Limited "Epip ComplexAssam, INDIA3
4TIL HEALTHCARE PVT LTDIrugulam Post, INDIA2
5Noveon IncCincinnati, UNITED STA2
6Comercializadora Spb SaMedellin, COLOMBIA2
7Patanjali Ayurved LimitedHaridwar, INDIA2
8Reckitt BenckiserUttarakhand, INDIA2
9Komal ImpexMumbai, INDIA1
10Lesepidado, S.r.l.Castel San Pietro Terme, ITALY1
11Hindustan Unilever LtdAssam, INDIA1
12Colgate-Palmolive (India) Ltd.Jhar Majri, INDIA1
13Waris Salah FarahAl Khobar, SAUDI ARAB1
14Ajanta Medicals PVT.LTD.Ponda, INDIA1
15PT INTEGRATED HEALTHCAREJakarta, INDONESIA1
16GOLECHA HERBALS UNLIMITEDDelhi, INDIA1
17Colgate PalmoliveWarsaw, POLAND1
18TECHNATUREDIRINON, FRANCE1
19Matha Exports InternationalNew Delhi, INDIA1
20Riddhi InternationalSalawas, INDIA1

Recent Import Refusals

DateProductFirm
10/31/2025
DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
53IG01
Colgate PalmolivePOLAND
10/11/2024
SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
63RBY04
Colgate-Palmolive (India) Ltd.INDIA
9/28/2024
TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING)
53ED07
Ajanta Medicals PVT.LTD.INDIA
9/26/2024
CYPROHEPTADINE HCL (ANTI-HISTAMINIC)
61XBL14
TIL HEALTHCARE PVT LTDINDIA
9/28/2023
BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
53JY01
Reckitt BenckiserINDIA
1/11/2023
EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
66YDL99
Emami Limited "Epip ComplexINDIA
1/11/2023
HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
53ED01
Emami Limited "Epip ComplexINDIA
1/11/2023
HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
53ED01
Emami Limited "Epip ComplexINDIA
11/4/2020
CYPROHEPTADINE HCL (ANTI-HISTAMINIC)
61XBL14
TIL HEALTHCARE PVT LTDINDIA
1/23/2020
EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
66YCY99
PT INTEGRATED HEALTHCAREINDONESIA
1/10/2020
SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
63RAJ04
Hindustan Unilever LtdINDIA
12/26/2019
OTHER SKIN CARE PREPARATIONS, N.E.C.
53LD99
Enprani Co., Ltd.SOUTH KORE
8/26/2019
BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
53JL01
Nouvelle Parfumeria GandourIVORY COAS
8/26/2019
BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
53JL01
El Paradis CosmetiqueIVORY COAS
8/26/2019
OTHER SKIN CARE PREPARATIONS, N.E.C.
53LD99
Nouvelle Parfumeria GandourIVORY COAS

Frequently Asked Questions

What is FDA violation code 73?

73 is an FDA violation code that indicates: "The article appears to be a color additive the intended use of which is for the purpose of coloring only, and its packaging and labeling do not conform to regulations issued under section 721.". This violation is based on 502(m), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 73?

According to FDA Import Refusal data, there have been 44 import refusals issued for violation code 73, affecting 29 unique firms.

When was the most recent refusal for violation 73?

The most recent import refusal for violation 73 was on October 31, 2025.

What products are commonly refused for violation 73?

Products commonly refused under violation 73 include: DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS), SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC), TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING), CYPROHEPTADINE HCL (ANTI-HISTAMINIC), BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS). These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 73?

Violation code 73 is based on 502(m), 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.