Willmann & Pein Gmbh
⚠️ Moderate Risk
FEI: 3003982202 • Bevern, Schleswig-Holstein • GERMANY
FEI Number
3003982202
Location
Bevern, Schleswig-Holstein
Country
GERMANYAddress
Barkhorner Weg 6, , Bevern, Schleswig-Holstein, Germany
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/17/2004 | 76ELWMATERIAL, IMPRESSION | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 8/17/2004 | 76ELWMATERIAL, IMPRESSION | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 8/17/2004 | 76ELWMATERIAL, IMPRESSION | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 8/17/2004 | 76ELWMATERIAL, IMPRESSION | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 8/17/2004 | 76ELWMATERIAL, IMPRESSION | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 8/17/2004 | 76ELWMATERIAL, IMPRESSION | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 8/17/2004 | 76ELWMATERIAL, IMPRESSION | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 8/17/2004 | 76ELWMATERIAL, IMPRESSION | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 8/17/2004 | 76ELWMATERIAL, IMPRESSION | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 8/17/2004 | 76ELWMATERIAL, IMPRESSION | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 8/17/2004 | 76ELWMATERIAL, IMPRESSION | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Willmann & Pein Gmbh's FDA import refusal history?
Willmann & Pein Gmbh (FEI: 3003982202) has 11 FDA import refusal record(s) in our database, spanning from 8/17/2004 to 8/17/2004.
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. Willmann & Pein Gmbh's FEI number is 3003982202.
What types of violations has Willmann & Pein Gmbh received?
Willmann & Pein 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 Willmann & Pein Gmbh come from?
All FDA import refusal data for Willmann & Pein 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.