Wuhu Zhanghengchun Medicine Co., Ltd.
⚠️ High Risk
FEI: 2000046971 • Wuhu, Anhui • CHINA
FEI Number
2000046971
Location
Wuhu, Anhui
Country
CHINAAddress
Economic And Technical, Fengminghu North Road; Development Area, Wuhu, Anhui, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
UNSFDIETSP
The article appears to be a dietary supplement or 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.
DIET INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be for use as an ingredient in a dietary supplement and appears to be or may be otherwise unfit for food.
UNSFDIETLB
The article appears to be a dietary supplement or contain a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use set out in the labeling or, if none are set out in the labeling, under customary conditions of use.
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
EPHEDALK
The product is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a dietary supplement or a dietary ingredient that appears to contain ephedrine alkaloids, which presents an unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling, or if no conditions of use are suggested in the labeling, under ordinary conditions of use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/30/2007 | 54FAW99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 3120EPHEDALK | Los Angeles District Office (LOS-DO) |
| 5/2/2007 | 54FAW99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2200DIET INGRE | Los Angeles District Office (LOS-DO) |
| 5/2/2007 | 54FAW99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 8/29/2006 | 54FAW99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2460UNSFDIETLB | Los Angeles District Office (LOS-DO) |
| 8/2/2006 | 54FAW99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/2/2006 | 54FAW99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/2/2006 | 54FAW99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/2/2006 | 66YAA99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/2/2006 | 66YAA99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/23/2006 | 54FAW99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 2/21/2006 | 54FAW99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Los Angeles District Office (LOS-DO) | |
| 2/21/2006 | 54FAW99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Los Angeles District Office (LOS-DO) | |
| 2/21/2006 | 54FAW99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Wuhu Zhanghengchun Medicine Co., Ltd.'s FDA import refusal history?
Wuhu Zhanghengchun Medicine Co., Ltd. (FEI: 2000046971) has 13 FDA import refusal record(s) in our database, spanning from 2/21/2006 to 5/30/2007.
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. Wuhu Zhanghengchun Medicine Co., Ltd.'s FEI number is 2000046971.
What types of violations has Wuhu Zhanghengchun Medicine Co., Ltd. received?
Wuhu Zhanghengchun Medicine Co., Ltd. has been cited for 6 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 Wuhu Zhanghengchun Medicine Co., Ltd. come from?
All FDA import refusal data for Wuhu Zhanghengchun Medicine 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.