Oxyvita Ltd
⚠️ Moderate Risk
FEI: 3005949752 • London • UNITED KINGDOM
FEI Number
3005949752
Location
London
Country
UNITED KINGDOMAddress
117 Kinchcey Road, , London, , 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
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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
Refusal History
Frequently Asked Questions
What is Oxyvita Ltd's FDA import refusal history?
Oxyvita Ltd (FEI: 3005949752) has 1 FDA import refusal record(s) in our database, spanning from 10/15/2007 to 10/15/2007.
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. Oxyvita Ltd's FEI number is 3005949752.
What types of violations has Oxyvita Ltd received?
Oxyvita 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 Oxyvita Ltd come from?
All FDA import refusal data for Oxyvita 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.