X4 Labs Inc
⚠️ Moderate Risk
FEI: 3008196036 • Montreal, QUEBEC • CANADA
FEI Number
3008196036
Location
Montreal, QUEBEC
Country
CANADAAddress
5610 Bois Franc, , Montreal, 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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/24/2012 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New York District Office (NYK-DO) | |
| 7/24/2012 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New York District Office (NYK-DO) | |
| 7/24/2012 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New York District Office (NYK-DO) | |
| 7/24/2012 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New York District Office (NYK-DO) | |
| 9/14/2010 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 237NO PMA | New York District Office (NYK-DO) |
| 9/14/2010 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 237NO PMA | New York District Office (NYK-DO) |
| 9/14/2010 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 237NO PMA | New York District Office (NYK-DO) |
| 9/14/2010 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 237NO PMA | New York District Office (NYK-DO) |
| 9/2/2010 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New York District Office (NYK-DO) | |
| 9/2/2010 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | New York District Office (NYK-DO) | |
| 8/3/2010 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 237NO PMA | New York District Office (NYK-DO) |
| 8/3/2010 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 237NO PMA | New York District Office (NYK-DO) |
| 7/15/2010 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 237NO PMA | New York District Office (NYK-DO) |
Frequently Asked Questions
What is X4 Labs Inc's FDA import refusal history?
X4 Labs Inc (FEI: 3008196036) has 13 FDA import refusal record(s) in our database, spanning from 7/15/2010 to 7/24/2012.
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. X4 Labs Inc's FEI number is 3008196036.
What types of violations has X4 Labs Inc received?
X4 Labs Inc 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 X4 Labs Inc come from?
All FDA import refusal data for X4 Labs 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.