Corporam / Medicam
⚠️ Moderate Risk
FEI: 3007335364 • Montreal, Quebec • CANADA
FEI Number
3007335364
Location
Montreal, Quebec
Country
CANADAAddress
3805 Jean-Talon St W, , 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
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.
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.
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 PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
DV NAME
The article appears to be a device and its labeling fails to bear the proprietary or established name.
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/8/2012 | 78KOASURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES) | New Orleans District Office (NOL-DO) | |
| 6/7/2012 | 95REFSUNTAN BED, SUNLAMP PRODUCTS (CERTIFIED), NON-MEDICAL | New Orleans District Office (NOL-DO) | |
| 12/16/2011 | 79ONFPOWERED LIGHT BASED NON-LASER SURGICAL INSTRUMENT WITH THERMAL EFFECT | New Orleans District Office (NOL-DO) | |
| 12/12/2011 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | New Orleans District Office (NOL-DO) | |
| 12/12/2011 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | New Orleans District Office (NOL-DO) | |
| 12/9/2011 | 79ONFPOWERED LIGHT BASED NON-LASER SURGICAL INSTRUMENT WITH THERMAL EFFECT | New Orleans District Office (NOL-DO) | |
| 12/5/2011 | 79FTCLIGHT, ULTRAVIOLET, DERMATOLOGICAL | New Orleans District Office (NOL-DO) | |
| 10/18/2011 | 95REFSUNTAN BED, SUNLAMP PRODUCTS (CERTIFIED), NON-MEDICAL | New Orleans District Office (NOL-DO) | |
| 9/30/2011 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/31/2011 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 126FAILS STD | New Orleans District Office (NOL-DO) |
| 8/23/2011 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | New Orleans District Office (NOL-DO) | |
| 8/12/2011 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | New Orleans District Office (NOL-DO) | |
| 3/10/2011 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | New Orleans District Office (NOL-DO) | |
| 6/24/2010 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 508NO 510(K) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Corporam / Medicam's FDA import refusal history?
Corporam / Medicam (FEI: 3007335364) has 14 FDA import refusal record(s) in our database, spanning from 6/24/2010 to 6/8/2012.
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. Corporam / Medicam's FEI number is 3007335364.
What types of violations has Corporam / Medicam received?
Corporam / Medicam has been cited for 9 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 Corporam / Medicam come from?
All FDA import refusal data for Corporam / Medicam 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.