Orthopedic University Essen
⚠️ Moderate Risk
FEI: 3003813929 • Essen, North Rhine-Westphalia • GERMANY
FEI Number
3003813929
Location
Essen, North Rhine-Westphalia
Country
GERMANYAddress
Hufelandstr. 55, , Essen, 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
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/24/2002 | 57JJ03BONE | 78STERILITY | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Orthopedic University Essen's FDA import refusal history?
Orthopedic University Essen (FEI: 3003813929) has 1 FDA import refusal record(s) in our database, spanning from 11/24/2002 to 11/24/2002.
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. Orthopedic University Essen's FEI number is 3003813929.
What types of violations has Orthopedic University Essen received?
Orthopedic University Essen 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 Orthopedic University Essen come from?
All FDA import refusal data for Orthopedic University Essen 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.