Techlem Medical Corporation
✅ Low Risk
FEI: 3000134760 • Mississauga, Ontario • CANADA
FEI Number
3000134760
Location
Mississauga, Ontario
Country
CANADAAddress
6890 Pacific Cir, , Mississauga, Ontario, Canada
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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
Frequently Asked Questions
What is Techlem Medical Corporation's FDA import refusal history?
Techlem Medical Corporation (FEI: 3000134760) has 2 FDA import refusal record(s) in our database, spanning from 12/13/2011 to 6/21/2013.
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. Techlem Medical Corporation's FEI number is 3000134760.
What types of violations has Techlem Medical Corporation received?
Techlem Medical Corporation has been cited for 1 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 Techlem Medical Corporation come from?
All FDA import refusal data for Techlem Medical Corporation 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.