Sterigenics
✅ Low Risk
FEI: 3004196498 • Scarborough, ONTARIO • CANADA
FEI Number
3004196498
Location
Scarborough, ONTARIO
Country
CANADAAddress
16 Comstock Rd Uni, , Scarborough, 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
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/31/2005 | 79LRPTRAY, SURGICAL | 341REGISTERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sterigenics's FDA import refusal history?
Sterigenics (FEI: 3004196498) has 1 FDA import refusal record(s) in our database, spanning from 5/31/2005 to 5/31/2005.
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. Sterigenics's FEI number is 3004196498.
What types of violations has Sterigenics received?
Sterigenics 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 Sterigenics come from?
All FDA import refusal data for Sterigenics 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.