Quality Elastics Ltd. QMD Medical
⚠️ Moderate Risk
FEI: 3001439970 • Montreal, Quebec • CANADA
FEI Number
3001439970
Location
Montreal, Quebec
Country
CANADAAddress
7250 Marconi St, , Montreal, Quebec, 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/11/2003 | 80MXINONABSORBABLE GAUZE, SURGICAL SPONGE & WOUND DRESSING FOR EXTERNAL USE (WITH A DRUG) | Detroit District Office (DET-DO) | |
| 9/11/2003 | 80MXINONABSORBABLE GAUZE, SURGICAL SPONGE & WOUND DRESSING FOR EXTERNAL USE (WITH A DRUG) | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Quality Elastics Ltd. QMD Medical's FDA import refusal history?
Quality Elastics Ltd. QMD Medical (FEI: 3001439970) has 2 FDA import refusal record(s) in our database, spanning from 9/11/2003 to 9/11/2003.
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. Quality Elastics Ltd. QMD Medical's FEI number is 3001439970.
What types of violations has Quality Elastics Ltd. QMD Medical received?
Quality Elastics Ltd. QMD Medical 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 Quality Elastics Ltd. QMD Medical come from?
All FDA import refusal data for Quality Elastics Ltd. QMD Medical 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.