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Varian Medical Systems U.K. Ltd.

⚠️ Moderate Risk

FEI: 5754 • Crawley, West Sussex • UNITED KINGDOM

FEI

FEI Number

5754

📍

Location

Crawley, West Sussex

🇬🇧
🏢

Address

Oncology House, Gatwick Road, Crawley, West Sussex, 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
3/22/2007
Latest Refusal
3/22/2007
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
3/22/2007
90IYDGENERATOR, LOW VOLTAGE, THERAPEUTIC X-RAY
508NO 510(K)
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Varian Medical Systems U.K. Ltd.'s FDA import refusal history?

Varian Medical Systems U.K. Ltd. (FEI: 5754) has 1 FDA import refusal record(s) in our database, spanning from 3/22/2007 to 3/22/2007.

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. Varian Medical Systems U.K. Ltd.'s FEI number is 5754.

What types of violations has Varian Medical Systems U.K. Ltd. received?

Varian Medical Systems U.K. 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 Varian Medical Systems U.K. Ltd. come from?

All FDA import refusal data for Varian Medical Systems U.K. 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.