Aalto Bio Reagents Ltd
⚠️ Moderate Risk
FEI: 1000196286 • Rathfarnham, Dublin • IRELAND
FEI Number
1000196286
Location
Rathfarnham, Dublin
Country
IRELANDAddress
14 Main Street, , Rathfarnham, Dublin, Ireland
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 PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
Frequently Asked Questions
What is Aalto Bio Reagents Ltd's FDA import refusal history?
Aalto Bio Reagents Ltd (FEI: 1000196286) has 1 FDA import refusal record(s) in our database, spanning from 6/11/2012 to 6/11/2012.
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. Aalto Bio Reagents Ltd's FEI number is 1000196286.
What types of violations has Aalto Bio Reagents Ltd received?
Aalto Bio Reagents 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 Aalto Bio Reagents Ltd come from?
All FDA import refusal data for Aalto Bio Reagents 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.