Kontinent Spedition Gmbh
⚠️ Moderate Risk
FEI: 3005988424 • Jena, Thuringia • GERMANY
FEI Number
3005988424
Location
Jena, Thuringia
Country
GERMANYAddress
Carl-Zeiss-Promenade 10, , Jena, Thuringia, 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/19/2004 | 95L30LASER PRINTERS | 476NO REGISTR | New York District Office (NYK-DO) |
| 9/12/2003 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 476NO REGISTR | New York District Office (NYK-DO) |
| 9/12/2003 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 476NO REGISTR | New York District Office (NYK-DO) |
| 9/12/2003 | 95L30LASER PRINTERS | 476NO REGISTR | New York District Office (NYK-DO) |
| 8/5/2003 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 476NO REGISTR | Cincinnati District Office (CIN-DO) |
| 12/27/2002 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 476NO REGISTR | New York District Office (NYK-DO) |
| 5/6/2002 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 476NO REGISTR | New York District Office (NYK-DO) |
| 4/15/2002 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/28/2001 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 476NO REGISTR | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Kontinent Spedition Gmbh's FDA import refusal history?
Kontinent Spedition Gmbh (FEI: 3005988424) has 9 FDA import refusal record(s) in our database, spanning from 10/28/2001 to 10/19/2004.
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. Kontinent Spedition Gmbh's FEI number is 3005988424.
What types of violations has Kontinent Spedition Gmbh received?
Kontinent Spedition 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 Kontinent Spedition Gmbh come from?
All FDA import refusal data for Kontinent Spedition 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.