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Jejoue (Cliq Ltd

⚠️ Moderate Risk

FEI: 3011057490 • Melton Mowbray • UNITED KINGDOM

FEI

FEI Number

3011057490

📍

Location

Melton Mowbray

🇬🇧
🏢

Address

Hallmark Consumer Services, , Melton Mowbray, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

41.6
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

5
Total Refusals
2
Unique Violations
6/2/2016
Latest Refusal
6/3/2015
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

165×

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.

5081×

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

DateProductViolationsDivision
6/2/2016
78LKYDEVICE, EXTERNAL PENILE RIGIDITY
16DIRECTIONS
New Orleans District Office (NOL-DO)
6/2/2016
78LKYDEVICE, EXTERNAL PENILE RIGIDITY
16DIRECTIONS
Division of Southeast Imports (DSEI)
1/12/2016
78LKYDEVICE, EXTERNAL PENILE RIGIDITY
16DIRECTIONS
508NO 510(K)
Division of Southeast Imports (DSEI)
9/3/2015
78LKYDEVICE, EXTERNAL PENILE RIGIDITY
16DIRECTIONS
New Orleans District Office (NOL-DO)
6/3/2015
78LKYDEVICE, EXTERNAL PENILE RIGIDITY
16DIRECTIONS
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Jejoue (Cliq Ltd's FDA import refusal history?

Jejoue (Cliq Ltd (FEI: 3011057490) has 5 FDA import refusal record(s) in our database, spanning from 6/3/2015 to 6/2/2016.

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. Jejoue (Cliq Ltd's FEI number is 3011057490.

What types of violations has Jejoue (Cliq Ltd received?

Jejoue (Cliq Ltd has been cited for 2 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 Jejoue (Cliq Ltd come from?

All FDA import refusal data for Jejoue (Cliq Ltd 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.