Non Friction Products Inc
⚠️ Moderate Risk
FEI: 3009282298 • Toronto, Ontario • CANADA
FEI Number
3009282298
Location
Toronto, Ontario
Country
CANADAAddress
551 Church St, , Toronto, 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
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).
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/19/2012 | 79NSZLUBRICANT, IMPLANT, INSERTION AID | Detroit District Office (DET-DO) | |
| 1/19/2012 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | Detroit District Office (DET-DO) | |
| 1/19/2012 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | Detroit District Office (DET-DO) | |
| 1/19/2012 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Non Friction Products Inc's FDA import refusal history?
Non Friction Products Inc (FEI: 3009282298) has 4 FDA import refusal record(s) in our database, spanning from 1/19/2012 to 1/19/2012.
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. Non Friction Products Inc's FEI number is 3009282298.
What types of violations has Non Friction Products Inc received?
Non Friction Products Inc has been cited for 3 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 Non Friction Products Inc come from?
All FDA import refusal data for Non Friction Products 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.