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VEREINIGTE PAPIERWARENFABRIKEN GMBH

⚠️ Moderate Risk

FEI: 3019838343 • Feuchtwangen, Bavaria • GERMANY

FEI

FEI Number

3019838343

📍

Location

Feuchtwangen, Bavaria

🇩🇪

Country

GERMANY
🏢

Address

Industriestr. 6, , Feuchtwangen, Bavaria, Germany

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/17/2022
Latest Refusal
3/17/2022
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
9.5×20%
Frequency
10.0×10%
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

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
3/17/2022
82OCBRT-PCR MULTIGENE EXPRESSION TEST, SENTINEL LYMPH NODE, CANCER METASTASIS DETECTION
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is VEREINIGTE PAPIERWARENFABRIKEN GMBH's FDA import refusal history?

VEREINIGTE PAPIERWARENFABRIKEN GMBH (FEI: 3019838343) has 1 FDA import refusal record(s) in our database, spanning from 3/17/2022 to 3/17/2022.

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. VEREINIGTE PAPIERWARENFABRIKEN GMBH's FEI number is 3019838343.

What types of violations has VEREINIGTE PAPIERWARENFABRIKEN GMBH received?

VEREINIGTE PAPIERWARENFABRIKEN 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 VEREINIGTE PAPIERWARENFABRIKEN GMBH come from?

All FDA import refusal data for VEREINIGTE PAPIERWARENFABRIKEN 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.