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VBM Medizintechnik GmbH

⚠️ Moderate Risk

FEI: 3002808440 • Sulz Am Neckar, Baden-Wurttemberg • GERMANY

FEI

FEI Number

3002808440

📍

Location

Sulz Am Neckar, Baden-Wurttemberg

🇩🇪

Country

GERMANY
🏢

Address

Einsteinstr. 1, , Sulz Am Neckar, Baden-Wurttemberg, Germany

Moderate Risk

FDA Import Risk Assessment

49.6
LowModerateHighCritical

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

Statistics

10
Total Refusals
1
Unique Violations
11/8/2011
Latest Refusal
10/26/2011
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
38.6×30%
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

278010×

DEVICEGMPS

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.

Refusal History

DateProductViolationsDivision
11/8/2011
73BTOTUBE, TRACHEOSTOMY (W/WO CONNECTOR)
2780DEVICEGMPS
Division of Southeast Imports (DSEI)
11/8/2011
73BTOTUBE, TRACHEOSTOMY (W/WO CONNECTOR)
2780DEVICEGMPS
Division of Southeast Imports (DSEI)
11/8/2011
73BTOTUBE, TRACHEOSTOMY (W/WO CONNECTOR)
2780DEVICEGMPS
Division of Southeast Imports (DSEI)
11/8/2011
73BTOTUBE, TRACHEOSTOMY (W/WO CONNECTOR)
2780DEVICEGMPS
Division of Southeast Imports (DSEI)
11/8/2011
73BTOTUBE, TRACHEOSTOMY (W/WO CONNECTOR)
2780DEVICEGMPS
Division of Southeast Imports (DSEI)
11/8/2011
73BTOTUBE, TRACHEOSTOMY (W/WO CONNECTOR)
2780DEVICEGMPS
Division of Southeast Imports (DSEI)
11/8/2011
73BTOTUBE, TRACHEOSTOMY (W/WO CONNECTOR)
2780DEVICEGMPS
Division of Southeast Imports (DSEI)
11/8/2011
73BTOTUBE, TRACHEOSTOMY (W/WO CONNECTOR)
2780DEVICEGMPS
Division of Southeast Imports (DSEI)
10/26/2011
73BTOTUBE, TRACHEOSTOMY (W/WO CONNECTOR)
2780DEVICEGMPS
Chicago District Office (CHI-DO)
10/26/2011
73BTOTUBE, TRACHEOSTOMY (W/WO CONNECTOR)
2780DEVICEGMPS
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is VBM Medizintechnik GmbH's FDA import refusal history?

VBM Medizintechnik GmbH (FEI: 3002808440) has 10 FDA import refusal record(s) in our database, spanning from 10/26/2011 to 11/8/2011.

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. VBM Medizintechnik GmbH's FEI number is 3002808440.

What types of violations has VBM Medizintechnik GmbH received?

VBM Medizintechnik 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 VBM Medizintechnik GmbH come from?

All FDA import refusal data for VBM Medizintechnik 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.