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Intersurgical Ltd. - Guernsey

⚠️ Moderate Risk

FEI: 3002807285 • Guernsey, Channel Islands • UNITED KINGDOM

FEI

FEI Number

3002807285

📍

Location

Guernsey, Channel Islands

🇬🇧
🏢

Address

Circuit House, Route De La Garenne; Pitronnerie Road, Guernsey, Channel Islands, United Kingdom

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/9/2010
Latest Refusal
3/9/2010
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

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
3/9/2010
73BZEHEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER
508NO 510(K)
New York District Office (NYK-DO)

Frequently Asked Questions

What is Intersurgical Ltd. - Guernsey's FDA import refusal history?

Intersurgical Ltd. - Guernsey (FEI: 3002807285) has 1 FDA import refusal record(s) in our database, spanning from 3/9/2010 to 3/9/2010.

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. Intersurgical Ltd. - Guernsey's FEI number is 3002807285.

What types of violations has Intersurgical Ltd. - Guernsey received?

Intersurgical Ltd. - Guernsey 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 Intersurgical Ltd. - Guernsey come from?

All FDA import refusal data for Intersurgical Ltd. - Guernsey 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.