Imasonic
⚠️ Moderate Risk
FEI: 3006700531 • Voray Sur L Ognon • FRANCE
FEI Number
3006700531
Location
Voray Sur L Ognon
Country
FRANCEAddress
Rue Des Savourots, , Voray Sur L Ognon, , France
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).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/19/2008 | 74JOPTRANSDUCER, ULTRASONIC | Minneapolis District Office (MIN-DO) | |
| 9/19/2008 | 74JOPTRANSDUCER, ULTRASONIC | Minneapolis District Office (MIN-DO) | |
| 9/19/2008 | 74JOPTRANSDUCER, ULTRASONIC | Minneapolis District Office (MIN-DO) | |
| 9/19/2008 | 74JOPTRANSDUCER, ULTRASONIC | Minneapolis District Office (MIN-DO) | |
| 9/19/2008 | 74JOPTRANSDUCER, ULTRASONIC | Minneapolis District Office (MIN-DO) | |
| 9/19/2008 | 74JOPTRANSDUCER, ULTRASONIC | Minneapolis District Office (MIN-DO) | |
| 9/19/2008 | 74JOPTRANSDUCER, ULTRASONIC | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is Imasonic's FDA import refusal history?
Imasonic (FEI: 3006700531) has 7 FDA import refusal record(s) in our database, spanning from 9/19/2008 to 9/19/2008.
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. Imasonic's FEI number is 3006700531.
What types of violations has Imasonic received?
Imasonic 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 Imasonic come from?
All FDA import refusal data for Imasonic 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.