Huishang Group Anhui Newenergy Co., Ltd.
⚠️ Moderate Risk
FEI: 3009508712 • Hefei, Anhui • CHINA
FEI Number
3009508712
Location
Hefei, Anhui
Country
CHINAAddress
258 Wuhulu, Baohe, Hefei, Anhui, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/9/2009 | 54YCB99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/8/2008 | 74DXQCUFF, BLOOD-PRESSURE | New York District Office (NYK-DO) | |
| 9/14/2005 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 249FILTHY | Division of Southeast Imports (DSEI) |
| 9/14/2005 | 54FBT26STEPHANIA (FANGJI), (HERBAL & BOTANICALS, NOT TEAS) | 218LIST INGRE | Division of Southeast Imports (DSEI) |
| 9/14/2005 | 54FBT73AKEBIA (HERBAL & BOTANICALS, NOT TEAS) | 218LIST INGRE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Huishang Group Anhui Newenergy Co., Ltd.'s FDA import refusal history?
Huishang Group Anhui Newenergy Co., Ltd. (FEI: 3009508712) has 5 FDA import refusal record(s) in our database, spanning from 9/14/2005 to 1/9/2009.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Huishang Group Anhui Newenergy Co., Ltd.'s FEI number is 3009508712.
What types of violations has Huishang Group Anhui Newenergy Co., Ltd. received?
Huishang Group Anhui Newenergy Co., Ltd. has been cited for 5 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Huishang Group Anhui Newenergy Co., Ltd. come from?
All FDA import refusal data for Huishang Group Anhui Newenergy Co., Ltd. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.