ImportRefusal LogoImportRefusal

Wintersteiger Ag

⚠️ Moderate Risk

FEI: 3009203894 • Innkreis • AUSTRIA

FEI

FEI Number

3009203894

📍

Location

Innkreis

🇦🇹

Country

AUSTRIA
🏢

Address

Dimmelstr 9, , Innkreis, , Austria

Moderate Risk

FDA Import Risk Assessment

33.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
4/17/2012
Latest Refusal
4/17/2012
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

1185×

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).

Refusal History

DateProductViolationsDivision
4/17/2012
74LLKLEGGING, COMPRESSION, NON-INFLATABLE
118NOT LISTED
Southwest Import District Office (SWI-DO)
4/17/2012
74LLKLEGGING, COMPRESSION, NON-INFLATABLE
118NOT LISTED
Southwest Import District Office (SWI-DO)
4/17/2012
74LLKLEGGING, COMPRESSION, NON-INFLATABLE
118NOT LISTED
Southwest Import District Office (SWI-DO)
4/17/2012
74LLKLEGGING, COMPRESSION, NON-INFLATABLE
118NOT LISTED
Southwest Import District Office (SWI-DO)
4/17/2012
74LLKLEGGING, COMPRESSION, NON-INFLATABLE
118NOT LISTED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Wintersteiger Ag's FDA import refusal history?

Wintersteiger Ag (FEI: 3009203894) has 5 FDA import refusal record(s) in our database, spanning from 4/17/2012 to 4/17/2012.

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. Wintersteiger Ag's FEI number is 3009203894.

What types of violations has Wintersteiger Ag received?

Wintersteiger Ag 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 Wintersteiger Ag come from?

All FDA import refusal data for Wintersteiger Ag 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.