Cedara Software Corp.
⚠️ Moderate Risk
FEI: 7440 • Mississauga, Ontario • CANADA
FEI Number
7440
Location
Mississauga, Ontario
Country
CANADAAddress
6509 Airport Rd, , Mississauga, 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
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.
Refusal History
Frequently Asked Questions
What is Cedara Software Corp.'s FDA import refusal history?
Cedara Software Corp. (FEI: 7440) has 2 FDA import refusal record(s) in our database, spanning from 2/20/2002 to 2/20/2002.
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. Cedara Software Corp.'s FEI number is 7440.
What types of violations has Cedara Software Corp. received?
Cedara Software Corp. 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 Cedara Software Corp. come from?
All FDA import refusal data for Cedara Software Corp. 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.