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Fabrik Gmbh Co Kg

⚠️ Moderate Risk

FEI: 3006197966 • Stolzenau, Lower Saxony • GERMANY

FEI

FEI Number

3006197966

📍

Location

Stolzenau, Lower Saxony

🇩🇪

Country

GERMANY
🏢

Address

Postfach 1127, , Stolzenau, Lower Saxony, Germany

Moderate Risk

FDA Import Risk Assessment

40.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
10/9/2007
Latest Refusal
7/2/2007
Earliest Refusal

Score Breakdown

Violation Severity
83.3×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

28002×

POSS N/STR

The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance, namely, potentially infectious organisms

1181×

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
10/9/2007
79KGXTAPE AND BANDAGE, ADHESIVE
2800POSS N/STR
New York District Office (NYK-DO)
7/2/2007
79KGXTAPE AND BANDAGE, ADHESIVE
118NOT LISTED
2800POSS N/STR
New York District Office (NYK-DO)

Frequently Asked Questions

What is Fabrik Gmbh Co Kg's FDA import refusal history?

Fabrik Gmbh Co Kg (FEI: 3006197966) has 2 FDA import refusal record(s) in our database, spanning from 7/2/2007 to 10/9/2007.

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. Fabrik Gmbh Co Kg's FEI number is 3006197966.

What types of violations has Fabrik Gmbh Co Kg received?

Fabrik Gmbh Co Kg 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 Fabrik Gmbh Co Kg come from?

All FDA import refusal data for Fabrik Gmbh Co Kg 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.