O'My Products Incorporated
⚠️ Moderate Risk
FEI: 3003092370 • North Vancouver, British Columbia • CANADA
FEI Number
3003092370
Location
North Vancouver, British Columbia
Country
CANADAAddress
188 Pemberton Ave, , North Vancouver, British Columbia, 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).
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).
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.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/22/2006 | 85HISCONDOM | Cincinnati District Office (CIN-DO) | |
| 5/5/2006 | 89IROVIBRATOR, THERAPEUTIC | Seattle District Office (SEA-DO) | |
| 5/5/2006 | 89IROVIBRATOR, THERAPEUTIC | Seattle District Office (SEA-DO) | |
| 5/5/2006 | 85HISCONDOM | Seattle District Office (SEA-DO) | |
| 5/19/2005 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | 118NOT LISTED | Seattle District Office (SEA-DO) |
| 12/14/2001 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is O'My Products Incorporated's FDA import refusal history?
O'My Products Incorporated (FEI: 3003092370) has 6 FDA import refusal record(s) in our database, spanning from 12/14/2001 to 9/22/2006.
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. O'My Products Incorporated's FEI number is 3003092370.
What types of violations has O'My Products Incorporated received?
O'My Products Incorporated has been cited for 4 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 O'My Products Incorporated come from?
All FDA import refusal data for O'My Products Incorporated 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.