Noveayr Respiratory Services Limited
⚠️ Moderate Risk
FEI: 3010166809 • Runcorn, Cheshire • UNITED KINGDOM
FEI Number
3010166809
Location
Runcorn, Cheshire
Country
UNITED KINGDOMAddress
9 Arkwright Road, , Runcorn, Cheshire, 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
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.
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
Frequently Asked Questions
What is Noveayr Respiratory Services Limited's FDA import refusal history?
Noveayr Respiratory Services Limited (FEI: 3010166809) has 2 FDA import refusal record(s) in our database, spanning from 4/7/2011 to 4/7/2011.
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. Noveayr Respiratory Services Limited's FEI number is 3010166809.
What types of violations has Noveayr Respiratory Services Limited received?
Noveayr Respiratory Services Limited 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 Noveayr Respiratory Services Limited come from?
All FDA import refusal data for Noveayr Respiratory Services Limited 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.