Violation Code: 3260
FDA Violation
Charge Code: NO ENGLISH
Violation Details
- Violation Code (ASC ID)
- 3260
- Charge Code
- NO ENGLISH
- Description
- Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
- Legal Section
- 502(c); 801(a)(3);Misbranding
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | SOLOTICA DISTRIBUIDORA DE | Sao Paulo, BRAZIL | 60 |
| 2 | EFFECT LLC | Harkov, UKRAINE | 24 |
| 3 | Daiso Industries Co., Ltd. | Higashihiroshima, JAPAN | 23 |
| 4 | SOLOTICA INDUSTRIA E COMERCIO LTDA | Sao Paulo, BRAZIL | 21 |
| 5 | DCS EXPORT | Banbury, UNITED KIN | 17 |
| 6 | Ethicon Endo-Surgery Inc | Blue Ash, UNITED STA | 16 |
| 7 | SUN WAH (KEI KEE) MEDICINE CO | Sheung Wan, HONG KONG | 14 |
| 8 | Kose | Chuo, JAPAN | 12 |
| 9 | NAUKOVO-VYROBNYCHA FARMATSEVTYCHNA KOMPANIYA EIM, TOV | Kharkiv, UKRAINE | 10 |
| 10 | KYIVSKY VITAMINNY ZAVOD, AT | Kopylivska Kyiv, UKRAINE | 10 |
| 11 | Arakaki Tsusho | Okinawa, JAPAN | 9 |
| 12 | Sagami Rubber Industries Co., Ltd. | Atsugi, JAPAN | 9 |
| 13 | Berlin-Chemie/Menarini Pharma GmbH | Berlin, GERMANY | 8 |
| 14 | I-see Vision Technology Inc | Hsinchu, TAIWAN | 8 |
| 15 | Tianjin Empecs Medical Device Co.,Ltd. | Tianjin, CHINA | 8 |
| 16 | Omron (Dalian) Co., Ltd. (Plant 1) | Dalian, CHINA | 7 |
| 17 | FARMATSEVTYCHNA KOMPANIYA ZDOROV'YA, TOV | Kharkiv, UKRAINE | 7 |
| 18 | Hug Communication | Tokyo, JAPAN | 7 |
| 19 | Rohto Pharmaceutical Co., Ltd. | Osaka, JAPAN | 7 |
| 20 | LENS COM.DE ARTIGOS OPTICOS LTDA | Curitiba, BRAZIL | 7 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/22/2026 | VITAMIN, N.E.C. 54ACK99 | NATURAL MEDY DISTRIBUCIONES SASCOLOMBIA |
| 1/21/2026 | DIETARY CONVENTIONAL FOODS, N.E.C. 41YYY99 | |
| 1/21/2026 | MOISTURIZING (SKIN CARE PREPARATIONS) 53LD06 | AERIM JUNGSOUTH KORE |
| 1/9/2026 | MOISTURIZING (SKIN CARE PREPARATIONS) 53LY06 | |
| 1/9/2026 | OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. 53GY99 | |
| 1/9/2026 | CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) 53LY01 | DEVER SOMNGAMTHAILAND |
| 1/8/2026 | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. 66YDY99 | WEDERMSOUTH KORE |
| 12/29/2025 | LENS, CONTACT (DISPOSABLE) 86MVN | Interojo Inc.SOUTH KORE |
| 12/29/2025 | LENS, CONTACT (DISPOSABLE) 86MVN | EISHO OPTICAL COJAPAN |
| 12/29/2025 | LENSES, SOFT CONTACT, DAILY WEAR 86LPL | PEGAVISION CORPORATIONTAIWAN |
| 12/21/2025 | FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS 41BYY99 | SWISS BIO PHARMA AGSWITZERLAN |
| 12/12/2025 | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) 53LC03 | |
| 12/3/2025 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VCY99 | HONG THAI MEDICINETHAILAND |
| 11/19/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | PharmaresearchSOUTH KORE |
| 11/19/2025 | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE 79LMH | PROFESSIONAL DERMA SASWITZERLAN |
Frequently Asked Questions
What is FDA violation code 3260?
3260 is an FDA violation code that indicates: "Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)". This violation is based on 502(c); 801(a)(3);Misbranding of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3260?
According to FDA Import Refusal data, there have been 1105 import refusals issued for violation code 3260, affecting 609 unique firms.
When was the most recent refusal for violation 3260?
The most recent import refusal for violation 3260 was on January 22, 2026.
What products are commonly refused for violation 3260?
Products commonly refused under violation 3260 include: VITAMIN, N.E.C., DIETARY CONVENTIONAL FOODS, N.E.C., MOISTURIZING (SKIN CARE PREPARATIONS), OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3260?
Violation code 3260 is based on 502(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.