GENEX DIAGNOSTICS INC
⚠️ Moderate Risk
FEI: 3013118068 • Vancouver, British Columbia • CANADA
FEI Number
3013118068
Location
Vancouver, British Columbia
Country
CANADAAddress
200-2806 Kingsway, , 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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/1/2021 | 75OYJDNA SPECIMEN COLLECTION, SALIVA | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/29/2019 | 75OYJDNA SPECIMEN COLLECTION, SALIVA | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/22/2019 | 75OYJDNA SPECIMEN COLLECTION, SALIVA | Division of Southeast Imports (DSEI) | |
| 3/23/2018 | 75OYJDNA SPECIMEN COLLECTION, SALIVA | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GENEX DIAGNOSTICS INC's FDA import refusal history?
GENEX DIAGNOSTICS INC (FEI: 3013118068) has 4 FDA import refusal record(s) in our database, spanning from 3/23/2018 to 3/1/2021.
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. GENEX DIAGNOSTICS INC's FEI number is 3013118068.
What types of violations has GENEX DIAGNOSTICS INC received?
GENEX DIAGNOSTICS 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 GENEX DIAGNOSTICS INC come from?
All FDA import refusal data for GENEX DIAGNOSTICS 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.