Al Zubair General Trading Est.
⚠️ Moderate Risk
FEI: 3004393917 • Dubai • UNITED ARAB EMIRATES
FEI Number
3004393917
Location
Dubai
Country
UNITED ARAB EMIRATESAddress
P.o. Box 12894, , Dubai, , 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
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).
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 |
|---|---|---|---|
| 4/21/2004 | 66GCK25DIMETHICONE 350 (SURGICAL/PROSTHETIC AID) | New York District Office (NYK-DO) | |
| 4/21/2004 | 61NAA67FLUVOXAMINE MALEATE (ANTI-DEPRESSANT) | New York District Office (NYK-DO) | |
| 4/21/2004 | 61NAA67FLUVOXAMINE MALEATE (ANTI-DEPRESSANT) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Al Zubair General Trading Est.'s FDA import refusal history?
Al Zubair General Trading Est. (FEI: 3004393917) has 3 FDA import refusal record(s) in our database, spanning from 4/21/2004 to 4/21/2004.
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. Al Zubair General Trading Est.'s FEI number is 3004393917.
What types of violations has Al Zubair General Trading Est. received?
Al Zubair General Trading Est. 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 Al Zubair General Trading Est. come from?
All FDA import refusal data for Al Zubair General Trading Est. 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.