Medoroux Medical Ltd.
⚠️ Moderate Risk
FEI: 3003312670 • London, FN • UNITED KINGDOM
FEI Number
3003312670
Location
London, FN
Country
UNITED KINGDOMAddress
11 Regency Parade, , London, FN, United Kingdom
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/1/2002 | 64JBV01OXYGEN (MEDICINAL GAS) | Los Angeles District Office (LOS-DO) | |
| 2/11/2002 | 64JCV01OXYGEN (MEDICINAL GAS) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 2/2/2002 | 64KCV99GAS, DILUENT N.E.C. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Medoroux Medical Ltd.'s FDA import refusal history?
Medoroux Medical Ltd. (FEI: 3003312670) has 3 FDA import refusal record(s) in our database, spanning from 2/2/2002 to 5/1/2002.
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. Medoroux Medical Ltd.'s FEI number is 3003312670.
What types of violations has Medoroux Medical Ltd. received?
Medoroux Medical Ltd. 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 Medoroux Medical Ltd. come from?
All FDA import refusal data for Medoroux Medical 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.