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 | Shiseido Co., Ltd. | Chuo, JAPAN | 56 |
| 9 | Unilever Manufacturera S. de R.L. de C.V. | Lerma, MEXICO | 51 |
| 10 | Coty Manufacturing UK Ltd. | Ashford, UNITED KIN | 45 |
| 11 | GUANGZHOU NATURAL BEAUTY CO. LTD | Guangzhou, CHINA | 45 |
| 12 | Hug Communication | Tokyo, JAPAN | 44 |
| 13 | Young Nails | Santa Fe Springs, UNITED STA | 41 |
| 14 | Laboratorios Dr. Collado S.A. | Santo Domingo Norte, DOMINICAN | 40 |
| 15 | ALEYDA FRANCO | Dajabon, DOMINICAN | 38 |
| 16 | la sincere co. | Osaka, JAPAN | 35 |
| 17 | PLATINA COSMETICOS LTDA | Uberaba, BRAZIL | 35 |
| 18 | Rohto Pharmaceutical Co., Ltd. | Osaka, JAPAN | 31 |
| 19 | Unilever Lever Faberge Deutschland | Mannheim, GERMANY | 31 |
| 20 | Schwan Cosmetics Germany GmbH & Co. KG | Heroldsberg, GERMANY | 30 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/13/2025 | OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. 53ED99 | Boe Dominicana SRLDOMINICAN |
| 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 |
| 11/10/2025 | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53EY06 | UCL Co., LtdSOUTH KORE |
| 10/29/2025 | OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. 53YD99 | EclaFinSOUTH KORE |
| 9/29/2025 | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06 | UCL Co., LtdSOUTH KORE |
| 9/29/2025 | CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) 53LY01 | CNF CO., LTD.SOUTH KORE |
| 9/19/2025 | OTHER SKIN CARE PREPARATIONS, N.E.C. 53LD99 | Enprani Co., Ltd.SOUTH KORE |
| 9/17/2025 | OTHER EYE MAKEUP PREPARATIONS, N.E.C. 53CK99 | Hanacos Co., Ltd.SOUTH KORE |
| 9/17/2025 | EYELASH AND EYEBROW TREATMENTS-GEL, OIL, PRIMER, CONDITIONERS, SERUM, FORTIFIERS (EYE MAKEUP PREPARA 53CD14 | ITOXICOSMETIC CO LTDSOUTH KORE |
| 9/17/2025 | PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) 53LY08 | COSMAX, INC.SOUTH KORE |
| 9/12/2025 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LD03 | HEALTHY AND SPORTMEXICO |
| 9/10/2025 | SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06 | MORENO PRODUCEMEXICO |
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 6942 import refusals issued for violation code 471, affecting 2320 unique firms.
When was the most recent refusal for violation 471?
The most recent import refusal for violation 471 was on December 13, 2025.
What products are commonly refused for violation 471?
Products commonly refused under violation 471 include: OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C., SHAMPOOS (HAIR PREPARATIONS, NON-COLORING), OTHER SKIN CARE PREPARATIONS, N.E.C.. 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.