AMD Medicom Inc.
⚠️ Moderate Risk
FEI: 3002677549 • Montreal, Quebec • CANADA
FEI Number
3002677549
Location
Montreal, Quebec
Country
CANADAAddress
2555 Ch de L'Aviation, , 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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/29/2023 | 76EAXMIRROR, MOUTH | Division of Southeast Imports (DSEI) | |
| 4/25/2022 | 76EAXMIRROR, MOUTH | Division of Southeast Imports (DSEI) | |
| 11/8/2011 | 80OIGRUBBER EXAMINATION GLOVES, POWDER-FREE | 118NOT LISTED | Detroit District Office (DET-DO) |
| 8/24/2011 | 79GERSPONGE, EXTERNAL | New England District Office (NWE-DO) |
Frequently Asked Questions
What is AMD Medicom Inc.'s FDA import refusal history?
AMD Medicom Inc. (FEI: 3002677549) has 4 FDA import refusal record(s) in our database, spanning from 8/24/2011 to 9/29/2023.
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. AMD Medicom Inc.'s FEI number is 3002677549.
What types of violations has AMD Medicom Inc. received?
AMD Medicom 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 AMD Medicom Inc. come from?
All FDA import refusal data for AMD Medicom 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.