IRISIOME
⚠️ Moderate Risk
FEI: 3019120079 • Pessac, Gironde • FRANCE
FEI Number
3019120079
Location
Pessac, Gironde
Country
FRANCEAddress
11 Avenue De Canteranne, , Pessac, Gironde, 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
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/6/2021 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 476NO REGISTR | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is IRISIOME's FDA import refusal history?
IRISIOME (FEI: 3019120079) has 1 FDA import refusal record(s) in our database, spanning from 8/6/2021 to 8/6/2021.
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. IRISIOME's FEI number is 3019120079.
What types of violations has IRISIOME received?
IRISIOME 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 IRISIOME come from?
All FDA import refusal data for IRISIOME 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.