Spidertech Inc
⚠️ High Risk
FEI: 3008368443 • Toronto, ONTARIO • CANADA
FEI Number
3008368443
Location
Toronto, ONTARIO
Country
CANADAAddress
115 Ridgetop Rd, , Toronto, ONTARIO, Canada
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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.
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 |
|---|---|---|---|
| 6/28/2013 | 80FQMBANDAGE, ELASTIC | 341REGISTERED | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
| 3/12/2012 | 80FQMBANDAGE, ELASTIC | 508NO 510(K) | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Spidertech Inc's FDA import refusal history?
Spidertech Inc (FEI: 3008368443) has 42 FDA import refusal record(s) in our database, spanning from 3/12/2012 to 6/28/2013.
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. Spidertech Inc's FEI number is 3008368443.
What types of violations has Spidertech Inc received?
Spidertech Inc 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 Spidertech Inc come from?
All FDA import refusal data for Spidertech Inc 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.