Creation Technologies Ltd
⚠️ Moderate Risk
FEI: 3000279201 • Burnaby, British Columbia • CANADA
FEI Number
3000279201
Location
Burnaby, British Columbia
Country
CANADAAddress
8977-8999 Fraserton Crt, , Burnaby, 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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 12/8/2022 | 80LHISET, I.V. FLUID TRANSER | Division of Southeast Imports (DSEI) | |
| 6/24/2022 | 80FRNPUMP, INFUSION | Division of Southeast Imports (DSEI) | |
| 4/14/2021 | 76NXVDIANOSTIC LIGHT, SOFT TISSUE DETECTOR | Division of Southeast Imports (DSEI) | |
| 11/7/2007 | 74DRQAMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL | New Orleans District Office (NOL-DO) | |
| 1/17/2007 | 74DRQAMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Creation Technologies Ltd's FDA import refusal history?
Creation Technologies Ltd (FEI: 3000279201) has 5 FDA import refusal record(s) in our database, spanning from 1/17/2007 to 12/8/2022.
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 Ltd's FEI number is 3000279201.
What types of violations has Creation Technologies Ltd received?
Creation Technologies Ltd has been cited for 4 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 Ltd come from?
All FDA import refusal data for Creation Technologies Ltd 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.