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Dr. Kurt Wolff GmbH & Co. KG

⚠️ Moderate Risk

FEI: 3005035400 • Bielefeld, North Rhine-westphalia • GERMANY

FEI

FEI Number

3005035400

📍

Location

Bielefeld, North Rhine-westphalia

🇩🇪

Country

GERMANY
🏢

Address

Johanneswerkstr. 34, , Bielefeld, North Rhine-westphalia, Germany

Moderate Risk

FDA Import Risk Assessment

27.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
6/19/2012
Latest Refusal
8/19/2011
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

4712×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

4732×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
6/19/2012
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
471CSTIC LBLG
New Orleans District Office (NOL-DO)
6/19/2012
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
471CSTIC LBLG
New Orleans District Office (NOL-DO)
8/19/2011
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
473LABELING
New Orleans District Office (NOL-DO)
8/19/2011
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
473LABELING
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Dr. Kurt Wolff GmbH & Co. KG's FDA import refusal history?

Dr. Kurt Wolff GmbH & Co. KG (FEI: 3005035400) has 4 FDA import refusal record(s) in our database, spanning from 8/19/2011 to 6/19/2012.

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. Dr. Kurt Wolff GmbH & Co. KG's FEI number is 3005035400.

What types of violations has Dr. Kurt Wolff GmbH & Co. KG received?

Dr. Kurt Wolff 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 Dr. Kurt Wolff GmbH & Co. KG come from?

All FDA import refusal data for Dr. Kurt Wolff 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.