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Tutogen Medical Gmbh

⚠️ Moderate Risk

FEI: 3002487675 • Erlangen, Bavaria • GERMANY

FEI

FEI Number

3002487675

📍

Location

Erlangen, Bavaria

🇩🇪

Country

GERMANY
🏢

Address

Wetterkreuz 19a, , Erlangen, Bavaria, Germany

Moderate Risk

FDA Import Risk Assessment

43.9
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
11/30/2005
Latest Refusal
6/23/2003
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
12.3×10%
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

4783×

TISSUE

This human cell, tissue, and cellular and tissue-based product is in violation of Section 361 of the Public Health Service Act.

Refusal History

DateProductViolationsDivision
11/30/2005
57JH01FASCIA (HUMAN MUSCULOSKELETAL TISSUES)
478TISSUE
Division of Southeast Imports (DSEI)
11/30/2005
57JH01FASCIA (HUMAN MUSCULOSKELETAL TISSUES)
478TISSUE
Division of Southeast Imports (DSEI)
6/23/2003
57JH01FASCIA (HUMAN MUSCULOSKELETAL TISSUES)
478TISSUE
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Tutogen Medical Gmbh's FDA import refusal history?

Tutogen Medical Gmbh (FEI: 3002487675) has 3 FDA import refusal record(s) in our database, spanning from 6/23/2003 to 11/30/2005.

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. Tutogen Medical Gmbh's FEI number is 3002487675.

What types of violations has Tutogen Medical Gmbh received?

Tutogen Medical 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 Tutogen Medical Gmbh come from?

All FDA import refusal data for Tutogen Medical 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.