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WOM World of Medicine AG

⚠️ Moderate Risk

FEI: 3001556604 • Berlin, Berlin • GERMANY

FEI

FEI Number

3001556604

📍

Location

Berlin, Berlin

🇩🇪

Country

GERMANY
🏢

Address

Salzufer 8, , Berlin, Berlin, Germany

Moderate Risk

FDA Import Risk Assessment

31.0
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
2/1/2002
Latest Refusal
2/1/2002
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

3413×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

4763×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

5083×

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
2/1/2002
78LNKLASER FOR GASTRO-UROLOGY USE
341REGISTERED
476NO REGISTR
508NO 510(K)
Los Angeles District Office (LOS-DO)
2/1/2002
78LNKLASER FOR GASTRO-UROLOGY USE
341REGISTERED
476NO REGISTR
508NO 510(K)
Los Angeles District Office (LOS-DO)
2/1/2002
78LNKLASER FOR GASTRO-UROLOGY USE
341REGISTERED
476NO REGISTR
508NO 510(K)
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is WOM World of Medicine AG's FDA import refusal history?

WOM World of Medicine AG (FEI: 3001556604) has 3 FDA import refusal record(s) in our database, spanning from 2/1/2002 to 2/1/2002.

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. WOM World of Medicine AG's FEI number is 3001556604.

What types of violations has WOM World of Medicine AG received?

WOM World of Medicine AG has been cited for 3 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 WOM World of Medicine AG come from?

All FDA import refusal data for WOM World of Medicine 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.