Medicam Inc
⚠️ Moderate Risk
FEI: 3005306695 • Montreal, QC • CANADA
FEI Number
3005306695
Location
Montreal, QC
Country
CANADAAddress
5285 Queen Mary, , Montreal, QC, 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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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 |
|---|---|---|---|
| 8/1/2008 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/21/2008 | 97RALMASSAGER, ULTRASONIC NON-MEDICAL DEVICES | New Orleans District Office (NOL-DO) | |
| 1/28/2008 | 80LDQDEVICE, GENERAL MEDICAL | New Orleans District Office (NOL-DO) | |
| 11/20/2006 | 79FTCLIGHT, ULTRAVIOLET, DERMATOLOGICAL | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Medicam Inc's FDA import refusal history?
Medicam Inc (FEI: 3005306695) has 4 FDA import refusal record(s) in our database, spanning from 11/20/2006 to 8/1/2008.
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. Medicam Inc's FEI number is 3005306695.
What types of violations has Medicam Inc received?
Medicam Inc has been cited for 4 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 Medicam Inc come from?
All FDA import refusal data for Medicam 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.