Universal Labs Ltd
⚠️ Moderate Risk
FEI: 3002711506 • Jubaiha, Amman • JORDAN
FEI Number
3002711506
Location
Jubaiha, Amman
Country
JORDANAddress
Suite 202- 2nd Floor- Caracas Center, Yajooz Street, Jubaiha, Amman, Jordan
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
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/4/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 9/15/2006 | 65LBJ99PROTECTANT N.E.C. | New York District Office (NYK-DO) | |
| 9/15/2006 | 65LBJ99PROTECTANT N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Universal Labs Ltd's FDA import refusal history?
Universal Labs Ltd (FEI: 3002711506) has 3 FDA import refusal record(s) in our database, spanning from 9/15/2006 to 10/4/2013.
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. Universal Labs Ltd's FEI number is 3002711506.
What types of violations has Universal Labs Ltd received?
Universal Labs Ltd 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 Universal Labs Ltd come from?
All FDA import refusal data for Universal Labs 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.