Violation Code: 471
FDA Violation
Charge Code: CSTIC LBLG
Violation Details
- Violation Code (ASC ID)
- 471
- Charge Code
- CSTIC LBLG
- Description
- The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
- Legal Section
- 602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | BUKAEV.RU LTD | Nizhniy Novgorod, RUSSIA | 121 |
| 2 | KALINA | Yekaterinburg, RUSSIA | 104 |
| 3 | Istituto Ganassiini | Milan, ITALY | 77 |
| 4 | Sinoropa | Muriel, GERMANY | 71 |
| 5 | Eveline Cosmetics | Lesznowola, POLAND | 69 |
| 6 | Unilever Mexico S de R.L. de C.V. | Jiutepec, MEXICO | 65 |
| 7 | NATURE REPUBLIC CO., LTD. | Seoul, SOUTH KORE | 62 |
| 8 | VANI COSMETICS INC | Pickering, CANADA | 58 |
| 9 | Shiseido Co., Ltd. | Chuo, JAPAN | 56 |
| 10 | Unilever Manufacturera S. de R.L. de C.V. | Lerma, MEXICO | 51 |
| 11 | Coty Manufacturing UK Ltd. | Ashford, UNITED KIN | 45 |
| 12 | GUANGZHOU NATURAL BEAUTY CO. LTD | Guangzhou, CHINA | 45 |
| 13 | Hug Communication | Tokyo, JAPAN | 44 |
| 14 | Young Nails | Santa Fe Springs, UNITED STA | 41 |
| 15 | Laboratorios Dr. Collado S.A. | Santo Domingo Norte, DOMINICAN | 40 |
| 16 | ALEYDA FRANCO | Dajabon, DOMINICAN | 38 |
| 17 | la sincere co. | Osaka, JAPAN | 35 |
| 18 | PLATINA COSMETICOS LTDA | Uberaba, BRAZIL | 35 |
| 19 | Rohto Pharmaceutical Co., Ltd. | Osaka, JAPAN | 31 |
| 20 | Unilever Lever Faberge Deutschland | Mannheim, GERMANY | 31 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/22/2026 | OTHER SKIN CARE PREPARATIONS, N.E.C. 53LC99 | P PHONELAOS |
| 1/21/2026 | OTHER SKIN CARE PREPARATIONS, N.E.C. 53LD99 | JP RETAILSINDIA |
| 1/9/2026 | SKIN FRESHENERS (SKIN CARE PREPARATIONS) 53LB09 | ASIA BRAND EXPORT INC.SOUTH KORE |
| 1/9/2026 | SKIN FRESHENERS (SKIN CARE PREPARATIONS) 53LB09 | SMART GLOBAL E COMMERCE CO LTDSOUTH KORE |
| 1/8/2026 | EYE SHADOW (EYE MAKEUP PREPARATIONS) 53CC03 | VANI COSMETICS INCCANADA |
| 1/8/2026 | EYE SHADOW (EYE MAKEUP PREPARATIONS) 53CC03 | VANI COSMETICS INCCANADA |
| 1/8/2026 | EYE SHADOW (EYE MAKEUP PREPARATIONS) 53CC03 | VANI COSMETICS INCCANADA |
| 1/8/2026 | EYE SHADOW (EYE MAKEUP PREPARATIONS) 53CC03 | VANI COSMETICS INCCANADA |
| 1/8/2026 | EYE SHADOW (EYE MAKEUP PREPARATIONS) 53CC03 | VANI COSMETICS INCCANADA |
| 1/8/2026 | EYE SHADOW (EYE MAKEUP PREPARATIONS) 53CC03 | VANI COSMETICS INCCANADA |
| 1/8/2026 | EYE SHADOW (EYE MAKEUP PREPARATIONS) 53CC03 | VANI COSMETICS INCCANADA |
| 1/8/2026 | EYE SHADOW (EYE MAKEUP PREPARATIONS) 53CC03 | VANI COSMETICS INCCANADA |
| 1/8/2026 | EYE SHADOW (EYE MAKEUP PREPARATIONS) 53CC03 | VANI COSMETICS INCCANADA |
| 1/8/2026 | EYE SHADOW (EYE MAKEUP PREPARATIONS) 53CC03 | VANI COSMETICS INCCANADA |
| 1/8/2026 | EYE SHADOW (EYE MAKEUP PREPARATIONS) 53CC03 | VANI COSMETICS INCCANADA |
Frequently Asked Questions
What is FDA violation code 471?
471 is an FDA violation code that indicates: "The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.". This violation is based on 602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 471?
According to FDA Import Refusal data, there have been 7005 import refusals issued for violation code 471, affecting 2326 unique firms.
When was the most recent refusal for violation 471?
The most recent import refusal for violation 471 was on January 22, 2026.
What products are commonly refused for violation 471?
Products commonly refused under violation 471 include: OTHER SKIN CARE PREPARATIONS, N.E.C., SKIN FRESHENERS (SKIN CARE PREPARATIONS), 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 471?
Violation code 471 is based on 602(a) and/or (b), and/or (c), 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.