Osiris Inc
⚠️ Moderate Risk
FEI: 3006472698 • Brampton, ON • CANADA
FEI Number
3006472698
Location
Brampton, ON
Country
CANADAAddress
2 Finley Rd, , Brampton, ON, 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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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).
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/26/2009 | 80BWJLOCATOR, ACUPUNCTURE POINT | New York District Office (NYK-DO) | |
| 10/22/2008 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | New York District Office (NYK-DO) | |
| 10/22/2008 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | New York District Office (NYK-DO) | |
| 10/22/2008 | 89MVTINSOLES, MAGNETIC, THERAPY, SUPPORTS | New York District Office (NYK-DO) | |
| 8/4/2008 | 80LDQDEVICE, GENERAL MEDICAL | 223FALSE | New York District Office (NYK-DO) |
| 7/3/2008 | 80LDQDEVICE, GENERAL MEDICAL | 223FALSE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Osiris Inc's FDA import refusal history?
Osiris Inc (FEI: 3006472698) has 6 FDA import refusal record(s) in our database, spanning from 7/3/2008 to 3/26/2009.
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. Osiris Inc's FEI number is 3006472698.
What types of violations has Osiris Inc received?
Osiris Inc has been cited for 5 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 Osiris Inc come from?
All FDA import refusal data for Osiris 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.