Aspex Group INC.
⚠️ Moderate Risk
FEI: 1000432969 • Montreal MONT-ROYAL, Quebec • CANADA
FEI Number
1000432969
Location
Montreal MONT-ROYAL, Quebec
Country
CANADAAddress
5440 PARE STREET SECOND FLOOR, , Montreal MONT-ROYAL, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/20/2016 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/20/2016 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/20/2016 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/26/2009 | 86HQZFRAME, SPECTACLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Aspex Group INC.'s FDA import refusal history?
Aspex Group INC. (FEI: 1000432969) has 4 FDA import refusal record(s) in our database, spanning from 8/26/2009 to 12/20/2016.
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. Aspex Group INC.'s FEI number is 1000432969.
What types of violations has Aspex Group INC. received?
Aspex Group INC. has been cited for 1 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 Aspex Group INC. come from?
All FDA import refusal data for Aspex Group 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.