Hager & Werken Gmbh
⚠️ Moderate Risk
FEI: 3003487388 • Duisburg, North Rhine-Westphalia • GERMANY
FEI Number
3003487388
Location
Duisburg, North Rhine-Westphalia
Country
GERMANYAddress
Ackerstr. 1, , Duisburg, North Rhine-Westphalia, 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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/5/2023 | 76EFWTOOTHBRUSH, MANUAL | Division of Southeast Imports (DSEI) | |
| 1/3/2011 | 76EFWTOOTHBRUSH, MANUAL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/3/2011 | 76EIYINSTRUMENT, FILLING, PLASTIC, DENTAL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/3/2011 | 76DZPINSTRUMENT, DIAMOND, DENTAL | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/3/2011 | 80KXFAPPLICATOR, ABSORBENT TIPPED, NON-STERILE | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Hager & Werken Gmbh's FDA import refusal history?
Hager & Werken Gmbh (FEI: 3003487388) has 5 FDA import refusal record(s) in our database, spanning from 1/3/2011 to 4/5/2023.
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. Hager & Werken Gmbh's FEI number is 3003487388.
What types of violations has Hager & Werken Gmbh received?
Hager & Werken Gmbh 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 Hager & Werken Gmbh come from?
All FDA import refusal data for Hager & Werken 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.