Lumen Dynamics Group Inc.
⚠️ Moderate Risk
FEI: 3008569850 • Mississauga, Ontario • CANADA
FEI Number
3008569850
Location
Mississauga, Ontario
Country
CANADAAddress
2260 Argentia Rd, , Mississauga, Ontario, 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 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/21/2022 | 95REXIR LASER ILLUMINATOR ONLY/NIGHT VISION SYSTEM, SAFETY, SECURITY, SURVEILLANCE LASER | 476NO REGISTR | Division of Northern Border Imports (DNBI) |
| 10/21/2022 | 95REXIR LASER ILLUMINATOR ONLY/NIGHT VISION SYSTEM, SAFETY, SECURITY, SURVEILLANCE LASER | 476NO REGISTR | Division of Northern Border Imports (DNBI) |
| 10/21/2022 | 95REXIR LASER ILLUMINATOR ONLY/NIGHT VISION SYSTEM, SAFETY, SECURITY, SURVEILLANCE LASER | 476NO REGISTR | Division of Northern Border Imports (DNBI) |
| 1/28/2021 | 75KHOFLUOROMETER, FOR CLINICAL USE | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/7/2011 | 86HPLDEVICE, FIXATION, AC-POWERED, OPHTHALMIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Lumen Dynamics Group Inc.'s FDA import refusal history?
Lumen Dynamics Group Inc. (FEI: 3008569850) has 5 FDA import refusal record(s) in our database, spanning from 10/7/2011 to 10/21/2022.
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. Lumen Dynamics Group Inc.'s FEI number is 3008569850.
What types of violations has Lumen Dynamics Group Inc. received?
Lumen Dynamics Group 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 Lumen Dynamics Group Inc. come from?
All FDA import refusal data for Lumen Dynamics 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.