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Wolf, Henke Sass, Gmbh

⚠️ Moderate Risk

FEI: 3002807224 • Tuttlingen, Baden-Wurttemberg • GERMANY

FEI

FEI Number

3002807224

📍

Location

Tuttlingen, Baden-Wurttemberg

🇩🇪

Country

GERMANY
🏢

Address

Kronenstr. 16, , Tuttlingen, Baden-Wurttemberg, Germany

Moderate Risk

FDA Import Risk Assessment

25.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
9/27/2013
Latest Refusal
3/6/2002
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
1.7×10%
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

1182×

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
9/27/2013
76EICSYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
118NOT LISTED
New Orleans District Office (NOL-DO)
3/6/2002
80LDQDEVICE, GENERAL MEDICAL
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Wolf, Henke Sass, Gmbh's FDA import refusal history?

Wolf, Henke Sass, Gmbh (FEI: 3002807224) has 2 FDA import refusal record(s) in our database, spanning from 3/6/2002 to 9/27/2013.

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. Wolf, Henke Sass, Gmbh's FEI number is 3002807224.

What types of violations has Wolf, Henke Sass, Gmbh received?

Wolf, Henke Sass, 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 Wolf, Henke Sass, Gmbh come from?

All FDA import refusal data for Wolf, Henke Sass, 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.