Total Applied Biosystems
✅ Low Risk
FEI: 3003460036 • Etobicoke, ON • CANADA
FEI Number
3003460036
Location
Etobicoke, ON
Country
CANADAAddress
105 Judge Rd, , Etobicoke, ON, 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 |
|---|---|---|---|
| 8/9/2002 | 75LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 341REGISTERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Total Applied Biosystems's FDA import refusal history?
Total Applied Biosystems (FEI: 3003460036) has 1 FDA import refusal record(s) in our database, spanning from 8/9/2002 to 8/9/2002.
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. Total Applied Biosystems's FEI number is 3003460036.
What types of violations has Total Applied Biosystems received?
Total Applied Biosystems 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 Total Applied Biosystems come from?
All FDA import refusal data for Total Applied Biosystems 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.