Osela Inc
⚠️ Moderate Risk
FEI: 3010232009 • Lachine, Quebec • CANADA
FEI Number
3010232009
Location
Lachine, Quebec
Country
CANADAAddress
1860 32e Ave, , Lachine, 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
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/9/2025 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 47NON STD | Division of Southeast Imports (DSEI) |
| 4/21/2025 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 476NO REGISTR | Division of West Coast Imports (DWCI) |
| 7/26/2013 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 47NON STD | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Osela Inc's FDA import refusal history?
Osela Inc (FEI: 3010232009) has 3 FDA import refusal record(s) in our database, spanning from 7/26/2013 to 10/9/2025.
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. Osela Inc's FEI number is 3010232009.
What types of violations has Osela Inc received?
Osela Inc has been cited for 2 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 Osela Inc come from?
All FDA import refusal data for Osela 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.