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VARIAN MEDICAL SYSTEMS HAAN GMBH

⚠️ Moderate Risk

FEI: 3016602874 • Haan, North Rhine-Westphalia • GERMANY

FEI

FEI Number

3016602874

📍

Location

Haan, North Rhine-Westphalia

🇩🇪

Country

GERMANY
🏢

Address

Rheinische Str. 2, , Haan, North Rhine-Westphalia, Germany

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
11/22/2004
Latest Refusal
11/22/2004
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

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
11/22/2004
90JAQSYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
47NON STD
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is VARIAN MEDICAL SYSTEMS HAAN GMBH's FDA import refusal history?

VARIAN MEDICAL SYSTEMS HAAN GMBH (FEI: 3016602874) has 1 FDA import refusal record(s) in our database, spanning from 11/22/2004 to 11/22/2004.

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 HAAN GMBH's FEI number is 3016602874.

What types of violations has VARIAN MEDICAL SYSTEMS HAAN GMBH received?

VARIAN MEDICAL SYSTEMS HAAN GMBH 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 HAAN GMBH come from?

All FDA import refusal data for VARIAN MEDICAL SYSTEMS HAAN GMBH 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.