Wentai Bio Technology Co Ltd
⚠️ Moderate Risk
FEI: 3012286187 • Shanghai • CHINA
FEI Number
3012286187
Location
Shanghai
Country
CHINAAddress
No 908 Yunre Roadnanqiao Town, , Shanghai, , 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
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 |
|---|---|---|---|
| 7/10/2017 | 65BCT01ACETYLCYSTEINE (MUCOLYTIC) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Wentai Bio Technology Co Ltd's FDA import refusal history?
Wentai Bio Technology Co Ltd (FEI: 3012286187) has 1 FDA import refusal record(s) in our database, spanning from 7/10/2017 to 7/10/2017.
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. Wentai Bio Technology Co Ltd's FEI number is 3012286187.
What types of violations has Wentai Bio Technology Co Ltd received?
Wentai Bio Technology Co Ltd has been cited for 1 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 Wentai Bio Technology Co Ltd come from?
All FDA import refusal data for Wentai Bio Technology 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.