Violation Code: 3862
FDA Violation
Charge Code: DIETARYING
Violation Details
- Violation Code (ASC ID)
- 3862
- Charge Code
- DIETARYING
- 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)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or , with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend.
- Legal Section
- 403(s)(2)(A),801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | FarmGroup | Barnaul, RUSSIA | 62 |
| 2 | Pharm Invest Jv | Chernovtsy, UKRAINE | 24 |
| 3 | UAB "EKV Logistik | Kovno, LITHUANIA | 18 |
| 4 | SUN WAH (KEI KEE) MEDICINE CO | Sheung Wan, HONG KONG | 14 |
| 5 | CENTER PHYTOCHAI | Solnechnogorsk, RUSSIA | 11 |
| 6 | Tan-Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret A.S. | Cekmekoy, TURKEY | 10 |
| 7 | SUN TEN PHARMACEUTICAL CO., LTD. | New Taipei City Taipei - Special Municip, TAIWAN | 10 |
| 8 | vitOrgan Arzneimittel GmbH | Ostfildern, GERMANY | 10 |
| 9 | OMEGA NUTRITION | Hidalgo Del Parral, MEXICO | 10 |
| 10 | Moskovskaya farmatsevticheskaya fabrika | Moscow, RUSSIA | 9 |
| 11 | Mount Kailash Rejuvenation Centre Inc. | Castries, SAINT LUCI | 9 |
| 12 | El Poder De La Herbolaria S De Rl | Guadalajara, MEXICO | 7 |
| 13 | THE 8TH ELEMENT | Cape Town, SOUTH AFRI | 6 |
| 14 | Swiss Caps Romania Srl | Cornu, ROMANIA | 5 |
| 15 | HARIHAR FOODS PVT LTD | AHMEDABAD, INDIA | 5 |
| 16 | OM FOODS | Surrey, CANADA | 5 |
| 17 | MEDICHIN NV | Diepenbeek, BELGIUM | 4 |
| 18 | ADRET RETAIL PVT LTD | Kolkata, INDIA | 4 |
| 19 | Nutrition Zone Products | Burnaby, CANADA | 3 |
| 20 | Ancient Greenfields | Coimbatore, INDIA | 3 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/12/2026 | L-CARNITINE (PROTEIN) 54CCL23 | |
| 1/12/2026 | L-CARNITINE (PROTEIN) 54CCL23 | |
| 1/12/2026 | L-CARNITINE (PROTEIN) 54CCL23 | |
| 1/12/2026 | L-CARNITINE (PROTEIN) 54CCL23 | |
| 1/8/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | |
| 1/8/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | |
| 1/8/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | |
| 1/8/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCR99 | |
| 1/8/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCR99 | |
| 1/8/2026 | VITAMIN C (ASCORBIC ACID) 54ACY13 | |
| 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 |
| 9/19/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | Jamieson LaboratoriesCANADA |
| 9/19/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | Jamieson LaboratoriesCANADA |
Frequently Asked Questions
What is FDA violation code 3862?
3862 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)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or , with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend.". This violation is based on 403(s)(2)(A),801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3862?
According to FDA Import Refusal data, there have been 382 import refusals issued for violation code 3862, affecting 136 unique firms.
When was the most recent refusal for violation 3862?
The most recent import refusal for violation 3862 was on January 12, 2026.
What products are commonly refused for violation 3862?
Products commonly refused under violation 3862 include: L-CARNITINE (PROTEIN), 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 3862?
Violation code 3862 is based on 403(s)(2)(A),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.