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A O Imaging Soluti

⚠️ Moderate Risk

FEI: 3005928290 • Neuss, North Rhine-Westphalia • GERMANY

FEI

FEI Number

3005928290

📍

Location

Neuss, North Rhine-Westphalia

🇩🇪

Country

GERMANY
🏢

Address

Nissanstr. 1, , Neuss, North Rhine-Westphalia, Germany

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/12/2006
Latest Refusal
10/12/2006
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

Refusal History

DateProductViolationsDivision
10/12/2006
95L22LASER PRODUCT FOR NON-MEDICAL USE
126FAILS STD
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is A O Imaging Soluti's FDA import refusal history?

A O Imaging Soluti (FEI: 3005928290) has 1 FDA import refusal record(s) in our database, spanning from 10/12/2006 to 10/12/2006.

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. A O Imaging Soluti's FEI number is 3005928290.

What types of violations has A O Imaging Soluti received?

A O Imaging Soluti 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 A O Imaging Soluti come from?

All FDA import refusal data for A O Imaging Soluti 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.