X4 Labs Inc.

⚠️ High Risk

FEI: 3006891323 • Montreal, QC • CANADA

FEI

FEI Number

3006891323

📍

Location

Montreal, QC

🇨🇦

Country

CANADA

🏢

Address

6855 De L'Epee Ave., , Montreal, QC, Canada

High Risk

FDA Import Risk Assessment

56.2

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

7/24/2012

Latest Refusal

7/14/2009

Earliest Refusal

Score Breakdown

Violation Severity

72.2×40%

Refusal Volume

57.6×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

1632×

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.

23729×

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).

1182×

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).

3412×

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).

5082×

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.

4841×

DV NAME

The article appears to be a device and its labeling fails to bear the proprietary or established name.

Refusal History

Date	Product	Violations	Division
7/24/2012	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	118NOT LISTED 16DIRECTIONS 508NO 510(K)	New York District Office (NYK-DO)
6/9/2011	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	484DV NAME	New Orleans District Office (NOL-DO)
6/9/2010	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS	Cincinnati District Office (CIN-DO)
4/21/2010	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 341REGISTERED	Cincinnati District Office (CIN-DO)
4/21/2010	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 341REGISTERED	Cincinnati District Office (CIN-DO)
1/7/2010	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
1/7/2010	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/23/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/23/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/23/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/23/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/23/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/23/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/23/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/23/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/23/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/23/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/23/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/23/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/23/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/23/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/23/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/23/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/22/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/22/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/22/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/22/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/22/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/22/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/22/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/22/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/22/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
9/18/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	16DIRECTIONS 237NO PMA	New York District Office (NYK-DO)
8/25/2009	78LKYDEVICE, EXTERNAL PENILE RIGIDITY	237NO PMA	Cincinnati District Office (CIN-DO)
7/14/2009	78NHUEXTENDER, PENILE, MECHANICAL	118NOT LISTED 508NO 510(K)	Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is X4 Labs Inc.'s FDA import refusal history?

X4 Labs Inc. (FEI: 3006891323) has 35 FDA import refusal record(s) in our database, spanning from 7/14/2009 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 3006891323.

What types of violations has X4 Labs Inc. received?

X4 Labs Inc. has been cited for 6 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.