Superex Canada Ltd
⚠️ Moderate Risk
FEI: 3000136785 • North York, Ontario • CANADA
FEI Number
3000136785
Location
North York, Ontario
Country
CANADAAddress
601 Gordon Baker Rd, , North York, Ontario, 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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/29/2013 | 79LRRKIT, FIRST AID | 341REGISTERED | Detroit District Office (DET-DO) |
| 8/29/2013 | 79LRRKIT, FIRST AID | 341REGISTERED | Detroit District Office (DET-DO) |
| 8/26/2013 | 79LRRKIT, FIRST AID | 341REGISTERED | Detroit District Office (DET-DO) |
| 8/6/2013 | 79LRRKIT, FIRST AID | 341REGISTERED | Detroit District Office (DET-DO) |
| 8/6/2013 | 79LRRKIT, FIRST AID | 341REGISTERED | Detroit District Office (DET-DO) |
| 1/5/2012 | 79LRRKIT, FIRST AID | 341REGISTERED | Detroit District Office (DET-DO) |
| 3/30/2011 | 79LRRKIT, FIRST AID | 341REGISTERED | Detroit District Office (DET-DO) |
| 12/30/2010 | 79LRRKIT, FIRST AID | 341REGISTERED | Detroit District Office (DET-DO) |
| 12/21/2010 | 79LRRKIT, FIRST AID | 341REGISTERED | Detroit District Office (DET-DO) |
| 12/21/2010 | 79LRRKIT, FIRST AID | 341REGISTERED | Detroit District Office (DET-DO) |
| 12/21/2010 | 79LRRKIT, FIRST AID | 341REGISTERED | Detroit District Office (DET-DO) |
| 12/17/2010 | 79LRRKIT, FIRST AID | 341REGISTERED | Detroit District Office (DET-DO) |
| 12/13/2010 | 79LRRKIT, FIRST AID | 341REGISTERED | Detroit District Office (DET-DO) |
| 12/13/2010 | 79LRRKIT, FIRST AID | 341REGISTERED | Detroit District Office (DET-DO) |
| 12/13/2010 | 79LRRKIT, FIRST AID | 341REGISTERED | Detroit District Office (DET-DO) |
| 12/13/2010 | 79LRRKIT, FIRST AID | 341REGISTERED | Detroit District Office (DET-DO) |
| 6/23/2009 | 79KGOSURGEON'S GLOVES | 118NOT LISTED | New York District Office (NYK-DO) |
| 2/11/2009 | 79LRRKIT, FIRST AID | 508NO 510(K) | New York District Office (NYK-DO) |
| 12/16/2008 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 12/16/2008 | 60LAK99ANALGESIC, N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 9/30/2008 | 73LYMDEVICE, CPR ASSIST | New York District Office (NYK-DO) | |
| 9/30/2008 | 73LYMDEVICE, CPR ASSIST | New York District Office (NYK-DO) | |
| 9/30/2008 | 73LYMDEVICE, CPR ASSIST | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Superex Canada Ltd's FDA import refusal history?
Superex Canada Ltd (FEI: 3000136785) has 23 FDA import refusal record(s) in our database, spanning from 9/30/2008 to 8/29/2013.
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. Superex Canada Ltd's FEI number is 3000136785.
What types of violations has Superex Canada Ltd received?
Superex Canada Ltd 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 Superex Canada Ltd come from?
All FDA import refusal data for Superex Canada 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.