Intelligent Engineering Canada I
⚠️ Moderate Risk
FEI: 3005612215 • Ottawa, ON • CANADA
FEI Number
3005612215
Location
Ottawa, ON
Country
CANADAAddress
14 Chamberlain Ave #300, , Ottawa, ON, 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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/24/2006 | 80FQMBANDAGE, ELASTIC | Detroit District Office (DET-DO) | |
| 4/24/2006 | 80FQMBANDAGE, ELASTIC | Detroit District Office (DET-DO) | |
| 4/24/2006 | 53LA01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Intelligent Engineering Canada I's FDA import refusal history?
Intelligent Engineering Canada I (FEI: 3005612215) has 3 FDA import refusal record(s) in our database, spanning from 4/24/2006 to 4/24/2006.
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. Intelligent Engineering Canada I's FEI number is 3005612215.
What types of violations has Intelligent Engineering Canada I received?
Intelligent Engineering Canada I 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 Intelligent Engineering Canada I come from?
All FDA import refusal data for Intelligent Engineering Canada I 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.