Violation Code: 73
FDA Violation
Charge Code: DRUG COLOR
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 Name | Location | Cases |
|---|---|---|---|
| 1 | Nouvelle Parfumeria Gandour | Abidjan 01, IVORY COAS | 7 |
| 2 | Johnson & Johnson Gmbh Ltd | Maidenhead, UNITED KIN | 3 |
| 3 | Emami Limited "Epip Complex | Assam, INDIA | 3 |
| 4 | Comercializadora Spb Sa | Medellin, COLOMBIA | 2 |
| 5 | TIL HEALTHCARE PVT LTD | Irugulam Post, INDIA | 2 |
| 6 | Reckitt Benckiser | Uttarakhand, INDIA | 2 |
| 7 | Noveon Inc | Cincinnati, UNITED STA | 2 |
| 8 | Patanjali Ayurved Limited | Haridwar, INDIA | 2 |
| 9 | Komal Impex | Mumbai, INDIA | 1 |
| 10 | Ktc Edibles Ltd | Wednesbury, UNITED KIN | 1 |
| 11 | Lesepidado, S.r.l. | Castel San Pietro Terme, ITALY | 1 |
| 12 | Matha Exports International | New Delhi, INDIA | 1 |
| 13 | PCB Creation S.A.S. | Benfeld, FRANCE | 1 |
| 14 | PT INTEGRATED HEALTHCARE | Jakarta, INDONESIA | 1 |
| 15 | Riddhi International | Salawas, INDIA | 1 |
| 16 | Saudi Nakhl | Jeddah, SAUDI ARAB | 1 |
| 17 | Shaltnaz Herbaz Intrenational | New Delhi, INDIA | 1 |
| 18 | TECHNATURE | DIRINON, FRANCE | 1 |
| 19 | The Himalaya Drug Company | Nalagarh, INDIA | 1 |
| 20 | The Himalaya Drug Company | Jeedimetla, INDIA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 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 | |
| 9/28/2024 | TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) 53ED07 | |
| 9/26/2024 | CYPROHEPTADINE HCL (ANTI-HISTAMINIC) 61XBL14 | |
| 9/28/2023 | BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JY01 | Reckitt BenckiserINDIA |
| 1/11/2023 | HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) 53ED01 | |
| 1/11/2023 | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. 66YDL99 | |
| 1/11/2023 | HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) 53ED01 | |
| 11/4/2020 | CYPROHEPTADINE HCL (ANTI-HISTAMINIC) 61XBL14 | |
| 1/23/2020 | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. 66YCY99 | PT INTEGRATED HEALTHCAREINDONESIA |
| 1/10/2020 | SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) 63RAJ04 | |
| 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 | El Paradis CosmetiqueIVORY COAS |
| 8/26/2019 | BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JL01 | Nouvelle Parfumeria GandourIVORY 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.