Eit Export Import Trading Gmbh
⚠️ Moderate Risk
FEI: 3002658485 • Warder • 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/3/2005 | 76ELWMATERIAL, IMPRESSION | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
| 6/3/2005 | 76ELWMATERIAL, IMPRESSION | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
| 6/3/2005 | 76EMACEMENT, DENTAL | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
| 6/3/2005 | 76EMACEMENT, DENTAL | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
| 6/3/2005 | 76EMACEMENT, DENTAL | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
| 6/3/2005 | 76EMACEMENT, DENTAL | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
| 6/3/2005 | 76EJJALLOY, AMALGAM | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
| 6/3/2005 | 76DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
| 6/3/2005 | 76EJKLINER, CAVITY, CALCIUM HYDROXIDE | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Eit Export Import Trading Gmbh's FDA import refusal history?
Eit Export Import Trading Gmbh (FEI: 3002658485) has 9 FDA import refusal record(s) in our database, spanning from 6/3/2005 to 6/3/2005.
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. Eit Export Import Trading Gmbh's FEI number is 3002658485.
What types of violations has Eit Export Import Trading Gmbh received?
Eit Export Import Trading 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 Eit Export Import Trading Gmbh come from?
All FDA import refusal data for Eit Export Import Trading 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.