Violation Code: 3864
FDA Violation
Charge Code: NCONTACT
Violation Details
- Violation Code (ASC ID)
- 3864
- Charge Code
- NCONTACT
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.
- Legal Section
- 403(y), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | ONE Group | Ashmore, AUSTRALIA | 70 |
| 2 | PHARMA GREEN S.R.L. | Falciano, ITALY | 69 |
| 3 | FarmGroup | Barnaul, RUSSIA | 58 |
| 4 | Equisalud S.L.U. | Huarte, SPAIN | 42 |
| 5 | Health Supplements | Tourlaville, FRANCE | 29 |
| 6 | UAB "EKV Logistik | Kovno, LITHUANIA | 23 |
| 7 | OMEGA NUTRITION | Hidalgo Del Parral, MEXICO | 23 |
| 8 | Eu Supplements | Bunnik, NETHERLAND | 22 |
| 9 | NEW LIFE NATURAL VEGETATION CELL | Freeport City, BAHAMAS | 22 |
| 10 | REMEDI WELLNESS AND SPA | Burnaby, CANADA | 20 |
| 11 | PLANTAS MEDICINALES DE MEXICO | DELEGACION XOCHIMILCO C.P, MEXICO | 19 |
| 12 | OKONET EUROPE KERESKEDELMI ES | Dabas, HUNGARY | 16 |
| 13 | BULK POWDERS USA LIMITED UNIT 1 | Colchester, UNITED KIN | 14 |
| 14 | SUN WAH (KEI KEE) MEDICINE CO | Sheung Wan, HONG KONG | 14 |
| 15 | GPNutrition, Ltd. | London, UNITED KIN | 13 |
| 16 | IMAGE HILL | Macgregor, CANADA | 13 |
| 17 | Wn Pharmaceuticals | Coquitlam, CANADA | 12 |
| 18 | Deciem Inc. | Toronto, CANADA | 11 |
| 19 | K N Wellness | Kanpur, INDIA | 11 |
| 20 | Greeniche Natural Health | Richmond Hill, CANADA | 11 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/10/2025 | VITAMIN E (TOCOPHEROL) 54ACY16 | ESPECIALIDADES NUTRITONMEXICO |
| 12/10/2025 | VITAMIN E (TOCOPHEROL) 54ACY16 | ESPECIALIDADES NUTRITONMEXICO |
| 12/8/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCL99 | REH HERBAL MANUFACTURING CORPPHILIPPINE |
| 12/3/2025 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCY99 | |
| 12/3/2025 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCY99 | Sheth BrothersINDIA |
| 12/3/2025 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCY99 | Sheth BrothersINDIA |
| 10/31/2025 | MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) 54ACA90 | |
| 10/31/2025 | MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) 54ACA90 | |
| 10/22/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | HK HONGTAILONG LIMITEDHONG KONG |
| 10/9/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCE99 | KUKAMONGA S A DEMEXICO |
| 10/9/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCE99 | KUKAMONGA S A DEMEXICO |
| 10/9/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCE99 | KUKAMONGA S A DEMEXICO |
| 10/9/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCE99 | KUKAMONGA S A DEMEXICO |
| 9/23/2025 | DIETARY CONVENTIONAL FOODS, N.E.C. 41YYT99 | LABORATORIOS NUTRIMEDMEXICO |
| 9/23/2025 | DIETARY CONVENTIONAL FOODS, N.E.C. 41YYY99 | LABORATORIOS NUTRIMEDMEXICO |
Frequently Asked Questions
What is FDA violation code 3864?
3864 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.". This violation is based on 403(y), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3864?
According to FDA Import Refusal data, there have been 1663 import refusals issued for violation code 3864, affecting 610 unique firms.
When was the most recent refusal for violation 3864?
The most recent import refusal for violation 3864 was on December 10, 2025.
What products are commonly refused for violation 3864?
Products commonly refused under violation 3864 include: VITAMIN E (TOCOPHEROL), VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C., HERBALS & BOTANICALS (NOT TEAS), N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3864?
Violation code 3864 is based on 403(y), 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.