AngioDynamics UK Ltd
⚠️ Moderate Risk
FEI: 3002936554 • Cambridge, CAM • UNITED KINGDOM
FEI Number
3002936554
Location
Cambridge, CAM
Country
UNITED KINGDOMAddress
Building 2000, Cambridge Research Park; Beach Drive, Cambridge, CAM, 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).
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).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/18/2012 | 63BCQ25FLUTICASONE PROPIONATE (BRONCHODILATOR) | New Orleans District Office (NOL-DO) | |
| 6/18/2012 | 63BCQ25FLUTICASONE PROPIONATE (BRONCHODILATOR) | New Orleans District Office (NOL-DO) | |
| 6/18/2012 | 63BCQ25FLUTICASONE PROPIONATE (BRONCHODILATOR) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is AngioDynamics UK Ltd's FDA import refusal history?
AngioDynamics UK Ltd (FEI: 3002936554) has 3 FDA import refusal record(s) in our database, spanning from 6/18/2012 to 6/18/2012.
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. AngioDynamics UK Ltd's FEI number is 3002936554.
What types of violations has AngioDynamics UK Ltd received?
AngioDynamics UK 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 AngioDynamics UK Ltd come from?
All FDA import refusal data for AngioDynamics UK 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.