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Wesley Jessen Pbh Ltd

⚠️ Moderate Risk

FEI: 3003257551 • Hampshire • UNITED KINGDOM

FEI

FEI Number

3003257551

📍

Location

Hampshire

🇬🇧
🏢

Address

1 Botley Roadhedge End Southampton, , Hampshire, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
7/11/2003
Latest Refusal
7/11/2003
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
7/11/2003
86HMCMONITOR, EYE MOVEMENT, DIAGNOSTIC
476NO REGISTR
Atlanta District Office (ATL-DO)

Frequently Asked Questions

What is Wesley Jessen Pbh Ltd's FDA import refusal history?

Wesley Jessen Pbh Ltd (FEI: 3003257551) has 1 FDA import refusal record(s) in our database, spanning from 7/11/2003 to 7/11/2003.

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. Wesley Jessen Pbh Ltd's FEI number is 3003257551.

What types of violations has Wesley Jessen Pbh Ltd received?

Wesley Jessen Pbh Ltd has been cited for 1 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 Wesley Jessen Pbh Ltd come from?

All FDA import refusal data for Wesley Jessen Pbh 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.