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Irlen Centre Kent

⚠️ Moderate Risk

FEI: 3002944830 • Maidstone, Kent • UNITED KINGDOM

FEI

FEI Number

3002944830

📍

Location

Maidstone, Kent

🇬🇧
🏢

Address

17 Ashford Drive, , Maidstone, Kent, United Kingdom

Moderate Risk

FDA Import Risk Assessment

31.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
4/22/2003
Latest Refusal
10/10/2002
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1181×

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).

841×

RX DEVICE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.

Refusal History

DateProductViolationsDivision
4/22/2003
86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY
118NOT LISTED
New Orleans District Office (NOL-DO)
10/10/2002
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
84RX DEVICE
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Irlen Centre Kent's FDA import refusal history?

Irlen Centre Kent (FEI: 3002944830) has 2 FDA import refusal record(s) in our database, spanning from 10/10/2002 to 4/22/2003.

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. Irlen Centre Kent's FEI number is 3002944830.

What types of violations has Irlen Centre Kent received?

Irlen Centre Kent 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 Irlen Centre Kent come from?

All FDA import refusal data for Irlen Centre Kent 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.