Violation Code: 474
FDA Violation
Charge Code: COSMETLBLG
Violation Details
- Violation Code (ASC ID)
- 474
- Charge Code
- COSMETLBLG
- Description
- It appears the label does not bear the common or usual name of the cosmetic.
- Legal Section
- 5(c)(3)(A); 801(a)(3) Misbranding
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | KALINA | Yekaterinburg, RUSSIA | 105 |
| 2 | Eveline Cosmetics | Lesznowola, POLAND | 55 |
| 3 | Nh Diffusion | Eguilles, FRANCE | 27 |
| 4 | Maxgut Biochemical Co., Ltd | Taichung, TAIWAN | 18 |
| 5 | Marcon Avista Sp. zoo | Halinow, POLAND | 16 |
| 6 | Shenzhen Huajianfa Trading Co Ltd | Beijing, CHINA | 15 |
| 7 | Heaven Health And Beauty Ltd | Shifnal, UNITED KIN | 13 |
| 8 | Dr Irena Eris S.A. | Piaseczno, POLAND | 12 |
| 9 | Antica Saponeria | Pesaro, ITALY | 12 |
| 10 | Pharma Vital | Plaza Panama, PANAMA | 11 |
| 11 | Shopbras Comercio E Disribuicao Ltd | Guarulhos, BRAZIL | 10 |
| 12 | Denova Pharmaceutical SAS | Cajica, COLOMBIA | 10 |
| 13 | Eveline Cosmetics | Zytnia, POLAND | 10 |
| 14 | Mission Hills, S.A. de C.V. | San Jose Iturbide, MEXICO | 10 |
| 15 | Noah Trading Co | Kowloon, HONG KONG | 8 |
| 16 | Laboratorios De Cosmetica Avanzada | Ciudad Autonoma Buenos Aires, ARGENTINA | 8 |
| 17 | Cosbel, S.A. de C.V. | Mexico, MEXICO | 8 |
| 18 | Sinoropa | Muriel, GERMANY | 7 |
| 19 | Proraso | San Giovanni Valdarno, ITALY | 7 |
| 20 | Eastern Shop Direct | Taipei, TAIWAN | 7 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/11/2025 | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06 | COLGATE PALMOLIVE (VIETNAM)VIETNAM |
| 12/11/2025 | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06 | COLGATE PALMOLIVE (VIETNAM)VIETNAM |
| 12/11/2025 | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06 | COLGATE PALMOLIVE (VIETNAM)VIETNAM |
| 11/10/2025 | OTHER SKIN CARE PREPARATIONS, N.E.C. 53LY99 | IBTJ CO LTDJAPAN |
| 10/1/2025 | TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) 53ED07 | |
| 10/1/2025 | TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) 53ED07 | |
| 9/26/2025 | CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) 53LD01 | New GPC Inc.GUYANA |
| 8/26/2025 | MOISTURIZING (SKIN CARE PREPARATIONS) 53LD06 | FAR EAST CABLECHINA |
| 7/31/2025 | CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) 53LY01 | Beiersdorf AGGERMANY |
| 7/31/2025 | CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) 53LY01 | Beiersdorf AGGERMANY |
| 7/31/2025 | CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) 53LY01 | Beiersdorf AGGERMANY |
| 6/30/2025 | SKIN FRESHENERS (SKIN CARE PREPARATIONS) 53LH09 | |
| 6/10/2025 | OTHER SKIN CARE PREPARATIONS, N.E.C. 53LY99 | OLAE MADE IN FRANCEFRANCE |
| 6/2/2025 | MOISTURIZING (SKIN CARE PREPARATIONS) 53LC06 | BULEXPO LTDBULGARIA |
| 5/19/2025 | HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI 53FY01 | MENELA COSMETICOS LTDABRAZIL |
Frequently Asked Questions
What is FDA violation code 474?
474 is an FDA violation code that indicates: "It appears the label does not bear the common or usual name of the cosmetic.". This violation is based on 5(c)(3)(A); 801(a)(3) Misbranding of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 474?
According to FDA Import Refusal data, there have been 1012 import refusals issued for violation code 474, affecting 425 unique firms.
When was the most recent refusal for violation 474?
The most recent import refusal for violation 474 was on December 11, 2025.
What products are commonly refused for violation 474?
Products commonly refused under violation 474 include: SHAMPOOS (HAIR PREPARATIONS, NON-COLORING), OTHER SKIN CARE PREPARATIONS, N.E.C., TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 474?
Violation code 474 is based on 5(c)(3)(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.