Winalite Uae Intl Gen Trade Co
⚠️ Moderate Risk
FEI: 3010724536 • Intl City • UNITED ARAB EMIRATES
FEI Number
3010724536
Location
Intl City
Country
UNITED ARAB EMIRATESAddress
Shop S16 Bldg N07, , Intl City, , United Arab Emirates
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
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/17/2014 | 54ABE17BIOTIN (VITAMIN H, COENZYME R) | 260FALSE | Los Angeles District Office (LOS-DO) |
| 4/17/2014 | 54ABE16VITAMIN E (TOCOPHEROL) | 260FALSE | Los Angeles District Office (LOS-DO) |
| 4/17/2014 | 60QAK56BENZOCAINE (ANESTHETIC) | 223FALSE | Los Angeles District Office (LOS-DO) |
| 4/17/2014 | 55PY01GLUCOSAMINE (PHARMACEUTIC NECESSITY) | 223FALSE | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Winalite Uae Intl Gen Trade Co's FDA import refusal history?
Winalite Uae Intl Gen Trade Co (FEI: 3010724536) has 4 FDA import refusal record(s) in our database, spanning from 4/17/2014 to 4/17/2014.
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. Winalite Uae Intl Gen Trade Co's FEI number is 3010724536.
What types of violations has Winalite Uae Intl Gen Trade Co received?
Winalite Uae Intl Gen Trade Co has been cited for 2 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 Winalite Uae Intl Gen Trade Co come from?
All FDA import refusal data for Winalite Uae Intl Gen Trade Co 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.