Violation Code: 3863
FDA Violation
Charge Code: PLANT PART
Violation Details
- Violation Code (ASC ID)
- 3863
- Charge Code
- PLANT PART
- 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(s)(2)(C) of the FD&C Act in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived.
- Legal Section
- 403(s)(2)(C), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | FarmGroup | Barnaul, RUSSIA | 60 |
| 2 | Canadian Phytopharmaceuticals | Richmond, CANADA | 11 |
| 3 | OMEGA NUTRITION | Hidalgo Del Parral, MEXICO | 11 |
| 4 | CENTER PHYTOCHAI | Solnechnogorsk, RUSSIA | 11 |
| 5 | LABORATORIOS DE FUERZA DE LA SALUD S.A DE CV | Distrito Federal, MEXICO | 10 |
| 6 | Prime Health Ltd | Port Coquitlam, CANADA | 10 |
| 7 | SUN TEN PHARMACEUTICAL CO., LTD. | New Taipei City Taipei - Special Municip, TAIWAN | 10 |
| 8 | Moskovskaya farmatsevticheskaya fabrika | Moscow, RUSSIA | 8 |
| 9 | JAIRAMDASS KHUSHIRAM | Navi Mumbai, INDIA | 8 |
| 10 | KOLMAR BNH CO.,LTD.(SBT) | Sejong, SOUTH KORE | 7 |
| 11 | El Poder De La Herbolaria S De Rl | Guadalajara, MEXICO | 6 |
| 12 | PLANTAFOOD MEDICAL GMBH | Leiningen, GERMANY | 6 |
| 13 | Goodcare Pharma Pvt. Ltd. | West Bengal, INDIA | 6 |
| 14 | HARIHAR FOODS PVT LTD | AHMEDABAD, INDIA | 5 |
| 15 | ADRET RETAIL PVT LTD | Kolkata, INDIA | 5 |
| 16 | Minature Wellness Pvt Ltd | Ahmedabad, INDIA | 5 |
| 17 | Hill Pharmaceutical Co.,Ltd | Yongzhou, CHINA | 4 |
| 18 | BIOPURE EU LTD. | Guntramsdorf, AUSTRIA | 4 |
| 19 | Xi'an Green Life Co.,Ltd | Xi'An, CHINA | 4 |
| 20 | Apis Vida Industria e Comercio Produtos Farmaceuticos Ltda | Bebedouro, BRAZIL | 4 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 5/14/2025 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCA99 | |
| 5/14/2025 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCA99 | |
| 5/14/2025 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCA99 | |
| 4/29/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | Earthley WellnessUNITED STA |
| 4/3/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YBY99 | |
| 4/3/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YBY99 | |
| 1/15/2025 | GINSENG (HERBAL & BOTANICALS, NOT TEAS) 54FCA12 | Power Health Products LtdUNITED KIN |
| 12/13/2024 | DIETARY CONVENTIONAL FOODS, N.E.C. 41YYY99 | |
| 12/11/2024 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | |
| 10/25/2024 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCR99 | |
| 10/25/2024 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCR99 | |
| 10/16/2024 | DIETARY CONVENTIONAL FOODS, N.E.C. 41YYY99 | |
| 10/16/2024 | DIETARY CONVENTIONAL FOODS, N.E.C. 41YYY99 | |
| 10/8/2024 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | Smart Sense Group LimitedHONG KONG |
| 10/2/2024 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | Smart Sense Group LimitedHONG KONG |
Frequently Asked Questions
What is FDA violation code 3863?
3863 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(s)(2)(C) of the FD&C Act in that the supplement contains an herb or other botanical described in section 201(ff)(1)(C), and the label or labeling of the supplement fails to identify any part of the plant from which the ingredient is derived.". This violation is based on 403(s)(2)(C), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3863?
According to FDA Import Refusal data, there have been 286 import refusals issued for violation code 3863, affecting 79 unique firms.
When was the most recent refusal for violation 3863?
The most recent import refusal for violation 3863 was on May 14, 2025.
What products are commonly refused for violation 3863?
Products commonly refused under violation 3863 include: HERBALS & BOTANICALS (NOT TEAS), N.E.C., VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3863?
Violation code 3863 is based on 403(s)(2)(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.