Ryanair
⚠️ Moderate Risk
FEI: 3004487229 • Standstead • UNITED KINGDOM
FEI Number
3004487229
Location
Standstead
Country
UNITED KINGDOMAddress
Unit 6004, , Standstead, , 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/28/2005 | 73BYGMASK, OXYGEN | 508NO 510(K) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Ryanair's FDA import refusal history?
Ryanair (FEI: 3004487229) has 1 FDA import refusal record(s) in our database, spanning from 3/28/2005 to 3/28/2005.
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. Ryanair's FEI number is 3004487229.
What types of violations has Ryanair received?
Ryanair has been cited for 1 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 Ryanair come from?
All FDA import refusal data for Ryanair 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.