Irsm
⚠️ Moderate Risk
FEI: 3010430384 • Edmonton, AB • CANADA
FEI Number
3010430384
Location
Edmonton, AB
Country
CANADAAddress
16940 87 Ave Nw, , Edmonton, AB, Canada
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/9/2023 | 77KHLHEARING-AID, MASTER | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Irsm's FDA import refusal history?
Irsm (FEI: 3010430384) has 1 FDA import refusal record(s) in our database, spanning from 3/9/2023 to 3/9/2023.
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. Irsm's FEI number is 3010430384.
What types of violations has Irsm received?
Irsm 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 Irsm come from?
All FDA import refusal data for Irsm 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.