TRANSOLUTION FZE
⚠️ High Risk
FEI: 3031661650 • Dubai, Dubai • UNITED ARAB EMIRATES
FEI Number
3031661650
Location
Dubai, Dubai
Country
UNITED ARAB EMIRATESAddress
Jebel Ali Free Zone Blue Shed North, Mina Jebel Ali St, Dubai, Dubai, United Arab Emirates
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
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/7/2024 | 75LFRGLUCOSE DEHYDROGENASE, GLUCOSE | Division of Southeast Imports (DSEI) | |
| 10/24/2024 | 75QLGINTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE WITH AUTOMATED INSU | Division of Southeast Imports (DSEI) | |
| 10/21/2024 | 75PYVHOSPITAL CONTINUOUS GLUCOSE MONITORING SYSTEM | Division of Southeast Imports (DSEI) | |
| 10/16/2024 | 75QLGINTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE WITH AUTOMATED INSU | Division of Southeast Imports (DSEI) | |
| 10/9/2024 | 80LHECONTROLLER, CLOSED-LOOP BLOOD GLUCOSE | Division of Southeast Imports (DSEI) | |
| 10/8/2024 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Division of Southeast Imports (DSEI) | |
| 10/7/2024 | 80LHECONTROLLER, CLOSED-LOOP BLOOD GLUCOSE | Division of Southeast Imports (DSEI) | |
| 10/1/2024 | 80LHECONTROLLER, CLOSED-LOOP BLOOD GLUCOSE | Division of Southeast Imports (DSEI) | |
| 9/24/2024 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is TRANSOLUTION FZE's FDA import refusal history?
TRANSOLUTION FZE (FEI: 3031661650) has 9 FDA import refusal record(s) in our database, spanning from 9/24/2024 to 11/7/2024.
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. TRANSOLUTION FZE's FEI number is 3031661650.
What types of violations has TRANSOLUTION FZE received?
TRANSOLUTION FZE has been cited for 3 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 TRANSOLUTION FZE come from?
All FDA import refusal data for TRANSOLUTION FZE 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.