Olympus Winter & IBE Gmbh
⚠️ Moderate Risk
FEI: 3002807798 • Hamburg, Hamburg • GERMANY
FEI Number
3002807798
Location
Hamburg, Hamburg
Country
GERMANYAddress
Kuehnstr. 61, , Hamburg, Hamburg, 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).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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 |
|---|---|---|---|
| 2/25/2020 | 78FASELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL | Division of Southeast Imports (DSEI) | |
| 5/31/2006 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | Florida District Office (FLA-DO) | |
| 5/31/2006 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | Florida District Office (FLA-DO) | |
| 5/31/2006 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | Florida District Office (FLA-DO) | |
| 5/31/2006 | 78FGASET, NEPHROSCOPE | Florida District Office (FLA-DO) | |
| 5/31/2006 | 78KOGENDOSCOPE AND/OR ACCESSORIES | Florida District Office (FLA-DO) | |
| 5/31/2006 | 78KOGENDOSCOPE AND/OR ACCESSORIES | Florida District Office (FLA-DO) | |
| 5/31/2006 | 78KOGENDOSCOPE AND/OR ACCESSORIES | Florida District Office (FLA-DO) | |
| 5/31/2006 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | Florida District Office (FLA-DO) | |
| 5/31/2006 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | Florida District Office (FLA-DO) | |
| 5/31/2006 | 78FGCURETHROSCOPE | Florida District Office (FLA-DO) | |
| 5/31/2006 | 78FGASET, NEPHROSCOPE | Florida District Office (FLA-DO) | |
| 5/31/2006 | 78KOGENDOSCOPE AND/OR ACCESSORIES | Florida District Office (FLA-DO) | |
| 5/31/2006 | 78KOGENDOSCOPE AND/OR ACCESSORIES | Florida District Office (FLA-DO) | |
| 5/31/2006 | 78FDCRESECTOSCOPE, WORKING ELEMENT | Florida District Office (FLA-DO) | |
| 5/31/2006 | 78KOGENDOSCOPE AND/OR ACCESSORIES | Florida District Office (FLA-DO) | |
| 5/31/2006 | 78KOGENDOSCOPE AND/OR ACCESSORIES | Florida District Office (FLA-DO) | |
| 5/31/2006 | 78KOGENDOSCOPE AND/OR ACCESSORIES | Florida District Office (FLA-DO) | |
| 5/31/2006 | 77JEKFORCEPS, BIOPSY, BRONCHOSCOPE (RIGID) | Florida District Office (FLA-DO) | |
| 5/31/2006 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | Florida District Office (FLA-DO) | |
| 5/31/2006 | 78FAJCYSTOSCOPE, DIAGNOSTIC | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Olympus Winter & IBE Gmbh's FDA import refusal history?
Olympus Winter & IBE Gmbh (FEI: 3002807798) has 21 FDA import refusal record(s) in our database, spanning from 5/31/2006 to 2/25/2020.
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. Olympus Winter & IBE Gmbh's FEI number is 3002807798.
What types of violations has Olympus Winter & IBE Gmbh received?
Olympus Winter & IBE Gmbh has been cited for 4 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 Olympus Winter & IBE Gmbh come from?
All FDA import refusal data for Olympus Winter & IBE 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.