Violation Code: 3100
FDA Violation
Charge Code: ANDRO
Violation Details
- Violation Code (ASC ID)
- 3100
- Charge Code
- ANDRO
- Description
- The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to declare and/or contain androstenedione, a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
- Legal Section
- 402(f)(1)(B),801(a)(3);ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Shaanxi Sincere Yokemate Import And Export Corp. | Xian, CHINA | 3 |
| 2 | Changzhou Dahua Imp. & Exp. (Group) Corp., Ltd. | Changzhou, CHINA | 2 |
| 3 | Hangzhou Yumei Biological Health Care Co., Ltd. | Hangzhou City, CHINA | 2 |
| 4 | SINOCHEM QINGDAO CO.,LTD. | Qingdao, CHINA | 2 |
| 5 | Zhejiang Xianju Junye Pharmaceutical Co., Ltd. | Taizhou, CHINA | 1 |
| 6 | Wu Xing Ming | Shenzhenshenzhen, CHINA | 1 |
| 7 | Nanjing Depont Pharmachem Co Ltd | Jianghsu, CHINA | 1 |
| 8 | Shanghai Desano Bio-Pharmaceutical Co., Ltd. | Shanghai, CHINA | 1 |
| 9 | Xian Yueasun Biological Technology | Xian, CHINA | 1 |
| 10 | Changsha Gree Biotechnology Co.Ltd. | Chagnsha, CHINA | 1 |
| 11 | CV. ARUL A2D | INDONESIA, INDONESIA | 1 |
| 12 | Nanjing Machinery | Nanjing, CHINA | 1 |
| 13 | Global Trans Maju empatempat | Jakarta, INDONESIA | 1 |
| 14 | United Parcel Service | Lachine, CANADA | 1 |
| 15 | Jiangsu Jiaerke Pharmaceuticals Group Corp., Ltd. | Changzhou, CHINA | 1 |
| 16 | Jnc Nutrachem Inc. | Ningbo, CHINA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 3/31/2017 | DEVICE/DIAG PROD FOR ANIMAL USED MORE THAN 1 SPECIES 68XYY20 | CV. ARUL A2DINDONESIA |
| 4/26/2016 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YYY99 | Global Trans Maju empatempatINDONESIA |
| 1/30/2015 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FYY99 | |
| 5/16/2013 | FOOD ADDITIVES FOR HUMAN USE, N.E.C. 46YH99 | |
| 5/14/2008 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YYY99 | |
| 5/31/2007 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YBR99 | Wu Xing MingCHINA |
| 10/19/2006 | MISCELLANEOUS PATENT MEDICINES, ETC. 66VAR99 | |
| 4/5/2005 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCH99 | United Parcel ServiceCANADA |
| 3/28/2005 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YAS99 | Nanjing MachineryCHINA |
| 3/1/2005 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YBT99 | Jnc Nutrachem Inc.CHINA |
| 2/28/2005 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YBR99 | |
| 2/28/2005 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YBR99 | |
| 1/5/2005 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YBS99 | |
| 12/29/2004 | ANDROGEN, N.E.C. 60NAR99 | |
| 12/29/2004 | ANDROGEN, N.E.C. 60NBR99 |
Frequently Asked Questions
What is FDA violation code 3100?
3100 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to declare and/or contain androstenedione, a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.". This violation is based on 402(f)(1)(B),801(a)(3);ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3100?
According to FDA Import Refusal data, there have been 21 import refusals issued for violation code 3100, affecting 16 unique firms.
When was the most recent refusal for violation 3100?
The most recent import refusal for violation 3100 was on March 31, 2017.
What products are commonly refused for violation 3100?
Products commonly refused under violation 3100 include: DEVICE/DIAG PROD FOR ANIMAL USED MORE THAN 1 SPECIES, VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C., HERBALS & BOTANICALS (NOT TEAS), N.E.C., FOOD ADDITIVES FOR HUMAN USE, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3100?
Violation code 3100 is based on 402(f)(1)(B),801(a)(3);ADULTERATION 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.