Biobasic Inc
✅ Low Risk
FEI: 3003239011 • Markham, ON • CANADA
FEI Number
3003239011
Location
Markham, ON
Country
CANADAAddress
315 Steelcase Rd E, , Markham, 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 |
|---|---|---|---|
| 1/12/2003 | 88LDTREAGENT, GENERAL PURPOSE | 341REGISTERED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Biobasic Inc's FDA import refusal history?
Biobasic Inc (FEI: 3003239011) has 1 FDA import refusal record(s) in our database, spanning from 1/12/2003 to 1/12/2003.
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. Biobasic Inc's FEI number is 3003239011.
What types of violations has Biobasic Inc received?
Biobasic Inc 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 Biobasic Inc come from?
All FDA import refusal data for Biobasic 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.