Mentor
⚠️ Moderate Risk
FEI: 3007861102 • Minneapolis, MN • UNITED STATES
FEI Number
3007861102
Location
Minneapolis, MN
Country
UNITED STATESAddress
6600 France Ave S, , Minneapolis, MN, United States
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/16/2010 | 80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/16/2010 | 78EXJDEVICE, INCONTINENCE, UROSHEATH TYPE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/16/2010 | 78EZDCATHETER, STRAIGHT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Mentor's FDA import refusal history?
Mentor (FEI: 3007861102) has 3 FDA import refusal record(s) in our database, spanning from 7/16/2010 to 7/16/2010.
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. Mentor's FEI number is 3007861102.
What types of violations has Mentor received?
Mentor 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 Mentor come from?
All FDA import refusal data for Mentor 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.