Violation Code: 3681
FDA Violation
Charge Code: NCONTACTS
Violation Details
- Violation Code (ASC ID)
- 3681
- Charge Code
- NCONTACTS
- Description
- The product is a dietary supplement that is marketed in the United States and appears to not have a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event.
- Legal Section
- 403(y), 801(2)(3); Misbranding
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Yamamoto Of Orient Inc | Pomona, UNITED STA | 12 |
| 2 | Eau Zone Huiles & Fragrances Lee | Montreal, CANADA | 12 |
| 3 | Dw Trading | West Sussex, UNITED KIN | 8 |
| 4 | Diveevo | Salkovo Village, RUSSIA | 8 |
| 5 | KITCHEN XPRESS OVERSEAS LTD | Gujarat, INDIA | 7 |
| 6 | Metabolics Ltd | Devizes, UNITED KIN | 7 |
| 7 | Pfizer Consumer Healthcare Limited | Berkshire, UNITED KIN | 6 |
| 8 | Assol Ltd | Sankt-Peterburg, RUSSIA | 6 |
| 9 | Nutraceutech Inc | Montreal, CANADA | 5 |
| 10 | STRAUSS NATURALS LTD | Kamloops, CANADA | 5 |
| 11 | Epigenetics | Devizes, UNITED KIN | 5 |
| 12 | NHS US, LLC | Lyndhurst, UNITED STA | 4 |
| 13 | Organika Health Products | Richmond, CANADA | 4 |
| 14 | Apiario Polenectar, Ltda. | Sao Paulo, BRAZIL | 3 |
| 15 | Les Laboratoiries Vachon | Levis, CANADA | 3 |
| 16 | Monfitello Inc. | Lachine, CANADA | 3 |
| 17 | Shenzhen Xin Yongtong Im&Ex Co Ltd | Shenzhen, CHINA | 3 |
| 18 | Nutricap Lab. | Farmingdale, UNITED STA | 3 |
| 19 | Korea Bio Medical Science Institute | Seoul, SOUTH KORE | 3 |
| 20 | Hair Burst Ltd | Sawston, UNITED KIN | 3 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/10/2015 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YYY99 | Elixa Ltd.UNITED KIN |
| 11/9/2015 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YBA99 | TrixstersGERMANY |
| 9/25/2015 | PROTEIN N.E.C. 54CCT99 | Mattias Edins StyrkeshopSWEDEN |
| 7/27/2015 | VITAMIN, N.E.C. 54AYY99 | Prime Nutrisource Inc.CANADA |
| 6/26/2015 | MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) 54AEY90 | Regena NeyGERMANY |
| 6/2/2015 | FATS AND LIPID SUBSTANCES, N.E.C. 54HAL99 | Organic Hemp Food ProductsDENMARK |
| 5/1/2015 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YDE99 | Hair Burst LtdUNITED KIN |
| 4/21/2015 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCH99 | Hair Burst LtdUNITED KIN |
| 4/7/2015 | BIOTIN (VITAMIN H, COENZYME R) 54AYH17 | Hairburst LtdUNITED KIN |
| 4/7/2015 | BIOTIN (VITAMIN H, COENZYME R) 54ABF17 | Hair Burst LtdUNITED KIN |
| 3/3/2015 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YEK99 | |
| 2/25/2015 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YYY99 | Tomoni AliveJAPAN |
| 11/24/2014 | VITAMIN A 54ACE01 | Parkacre LimitedUNITED KIN |
| 11/21/2014 | RED CLOVER (HERBAL & BOTANICAL TEAS) 54EBA56 | PharmaCare Laboratories Pty LtdAUSTRALIA |
| 10/23/2014 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCC99 | Parkacre LimitedUNITED KIN |
Frequently Asked Questions
What is FDA violation code 3681?
3681 is an FDA violation code that indicates: "The product is a dietary supplement that is marketed in the United States and appears to not have a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event.". This violation is based on 403(y), 801(2)(3); Misbranding of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3681?
According to FDA Import Refusal data, there have been 195 import refusals issued for violation code 3681, affecting 93 unique firms.
When was the most recent refusal for violation 3681?
The most recent import refusal for violation 3681 was on December 10, 2015.
What products are commonly refused for violation 3681?
Products commonly refused under violation 3681 include: VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C., PROTEIN N.E.C., VITAMIN, N.E.C., MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3681?
Violation code 3681 is based on 403(y), 801(2)(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.