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VDW GMBH

⚠️ Moderate Risk

FEI: 3002808442 • Munich, Bavaria • GERMANY

FEI

FEI Number

3002808442

📍

Location

Munich, Bavaria

🇩🇪

Country

GERMANY
🏢

Address

Bayerwaldstr. 15, , Munich, Bavaria, Germany

Moderate Risk

FDA Import Risk Assessment

38.4
LowModerateHighCritical

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

Statistics

19
Total Refusals
2
Unique Violations
9/25/2008
Latest Refusal
6/16/2008
Earliest Refusal

Score Breakdown

Violation Severity
34.8×40%
Refusal Volume
48.2×30%
Recency
0.0×20%
Frequency
100.0×10%
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

34119×

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).

1186×

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
9/25/2008
76EMRFILE, PERIODONTIC
341REGISTERED
Florida District Office (FLA-DO)
9/25/2008
76EMRFILE, PERIODONTIC
341REGISTERED
Florida District Office (FLA-DO)
9/25/2008
76EMRFILE, PERIODONTIC
341REGISTERED
Florida District Office (FLA-DO)
9/25/2008
76EMRFILE, PERIODONTIC
341REGISTERED
Florida District Office (FLA-DO)
9/25/2008
76EMRFILE, PERIODONTIC
341REGISTERED
Florida District Office (FLA-DO)
9/25/2008
76EMRFILE, PERIODONTIC
341REGISTERED
Florida District Office (FLA-DO)
9/25/2008
76EMRFILE, PERIODONTIC
341REGISTERED
Florida District Office (FLA-DO)
9/25/2008
76EMRFILE, PERIODONTIC
341REGISTERED
Florida District Office (FLA-DO)
9/25/2008
76EMRFILE, PERIODONTIC
341REGISTERED
Florida District Office (FLA-DO)
9/25/2008
76EMRFILE, PERIODONTIC
341REGISTERED
Florida District Office (FLA-DO)
9/25/2008
76EMRFILE, PERIODONTIC
341REGISTERED
Florida District Office (FLA-DO)
9/25/2008
76EMRFILE, PERIODONTIC
341REGISTERED
Florida District Office (FLA-DO)
9/25/2008
76EMRFILE, PERIODONTIC
341REGISTERED
Florida District Office (FLA-DO)
6/16/2008
76EKNPOINT, PAPER, ENDODONTIC
118NOT LISTED
341REGISTERED
Southwest Import District Office (SWI-DO)
6/16/2008
76EMRFILE, PERIODONTIC
118NOT LISTED
341REGISTERED
Southwest Import District Office (SWI-DO)
6/16/2008
76EAXMIRROR, MOUTH
118NOT LISTED
341REGISTERED
Southwest Import District Office (SWI-DO)
6/16/2008
76EKNPOINT, PAPER, ENDODONTIC
118NOT LISTED
341REGISTERED
Southwest Import District Office (SWI-DO)
6/16/2008
76DZADRILL, DENTAL, INTRAORAL
118NOT LISTED
341REGISTERED
Southwest Import District Office (SWI-DO)
6/16/2008
76EKLPOINT, SILVER, ENDODONTIC
118NOT LISTED
341REGISTERED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is VDW GMBH's FDA import refusal history?

VDW GMBH (FEI: 3002808442) has 19 FDA import refusal record(s) in our database, spanning from 6/16/2008 to 9/25/2008.

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. VDW GMBH's FEI number is 3002808442.

What types of violations has VDW GMBH received?

VDW GMBH has been cited for 2 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 VDW GMBH come from?

All FDA import refusal data for VDW 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.