Creation Technologies
⚠️ Moderate Risk
FEI: 3004927780 • Burnabyburnaby, BRITISH COLUMBIA • CANADA
FEI Number
3004927780
Location
Burnabyburnaby, BRITISH COLUMBIA
Country
CANADAAddress
3905 North Fraser Wayunit: Dock 1, , Burnabyburnaby, BRITISH COLUMBIA, 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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/6/2020 | 84GWQELECTROENCEPHALOGRAPH | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 4/6/2020 | 84GWQELECTROENCEPHALOGRAPH | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 4/6/2020 | 84GWQELECTROENCEPHALOGRAPH | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 11/2/2012 | 74LPCDEVICE, ANGIOPLASTY, LASER, CORONARY | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Creation Technologies's FDA import refusal history?
Creation Technologies (FEI: 3004927780) has 4 FDA import refusal record(s) in our database, spanning from 11/2/2012 to 4/6/2020.
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. Creation Technologies's FEI number is 3004927780.
What types of violations has Creation Technologies received?
Creation Technologies has been cited for 3 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 Creation Technologies come from?
All FDA import refusal data for Creation Technologies 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.