Violation Code: 475
FDA Violation
Charge Code: COSMETLBLG
Violation Details
- Violation Code (ASC ID)
- 475
- Charge Code
- COSMETLBLG
- Description
- It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
- Legal Section
- 5(c)(3)(B); 801(a)(3) Misbranding
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | KALINA | Yekaterinburg, RUSSIA | 104 |
| 2 | M Kappus Gmbh & Co | Offenbach Am Main, GERMANY | 71 |
| 3 | Coty Manufacturing UK Ltd. | Ashford, UNITED KIN | 45 |
| 4 | GUANGZHOU NATURAL BEAUTY CO. LTD | Guangzhou, CHINA | 44 |
| 5 | Sinoropa | Muriel, GERMANY | 43 |
| 6 | Unilever Lever Faberge Deutschland | Mannheim, GERMANY | 35 |
| 7 | PLATINA COSMETICOS LTDA | Uberaba, BRAZIL | 35 |
| 8 | Logona Naturkosmetik Und Heilmittel Hans Hansel Gmbh | Salzhemmendorf, GERMANY | 28 |
| 9 | Cellex-C International Inc. | Toronto, CANADA | 27 |
| 10 | Bielenda Kosmetyki Natural Sp Zo | Liszki, POLAND | 26 |
| 11 | Dr Irena Eris S.A. | Piaseczno, POLAND | 22 |
| 12 | NATURE REPUBLIC CO., LTD. | Seoul, SOUTH KORE | 20 |
| 13 | Gc Logistics Corporation | Hwaseong, SOUTH KORE | 20 |
| 14 | Young Nails | Santa Fe Springs, UNITED STA | 19 |
| 15 | Rafael A. Castillo | Santo Domingo De Guzman, DOMINICAN | 19 |
| 16 | Valmari Cosmetica De Resultaado | Sao Bendito, BRAZIL | 18 |
| 17 | Isha Crafts Private | Coimbatore, INDIA | 18 |
| 18 | Soapworks | Guelph, CANADA | 18 |
| 19 | Unilever Philippines, Inc. - Cavite Factory | Calabarzon, PHILIPPINE | 17 |
| 20 | Phcp | Mississauga, CANADA | 17 |
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 |
| 11/17/2025 | WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) 53LF10 | |
| 10/29/2025 | OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. 53YD99 | EclaFinSOUTH KORE |
| 10/16/2025 | OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. 53ED99 | CAVINKARE PVT LTDINDIA |
| 9/24/2025 | BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JY01 | UNILEVER PAKISTAN FOODS LIMITEDPAKISTAN |
| 9/24/2025 | BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JY01 | UNILEVER PAKISTAN FOODS LIMITEDPAKISTAN |
| 9/24/2025 | BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JY01 | UNILEVER PAKISTAN FOODS LIMITEDPAKISTAN |
| 8/8/2025 | BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) 53JY01 | Hemani InternationalPAKISTAN |
| 6/30/2025 | SKIN FRESHENERS (SKIN CARE PREPARATIONS) 53LH09 | |
| 6/20/2025 | EYE SHADOW (EYE MAKEUP PREPARATIONS) 53CF03 | |
| 6/10/2025 | OTHER SKIN CARE PREPARATIONS, N.E.C. 53LY99 | OLAE MADE IN FRANCEFRANCE |
| 5/19/2025 | HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI 53FY01 | MENELA COSMETICOS LTDABRAZIL |
| 5/16/2025 | OTHER SKIN CARE PREPARATIONS, N.E.C. 53LY99 | MIRACOSMETICCAMEROON |
Frequently Asked Questions
What is FDA violation code 475?
475 is an FDA violation code that indicates: "It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.". This violation is based on 5(c)(3)(B); 801(a)(3) Misbranding of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 475?
According to FDA Import Refusal data, there have been 3105 import refusals issued for violation code 475, affecting 1201 unique firms.
When was the most recent refusal for violation 475?
The most recent import refusal for violation 475 was on December 11, 2025.
What products are commonly refused for violation 475?
Products commonly refused under violation 475 include: SHAMPOOS (HAIR PREPARATIONS, NON-COLORING), WRINKLE SMOOTHING (SKIN CARE PREPARATIONS), OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 475?
Violation code 475 is based on 5(c)(3)(B); 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.