Instrumek B.V.
⚠️ Moderate Risk
FEI: 3000286413 • Schiedam, Zuid-Holland • NETHERLANDS
FEI Number
3000286413
Location
Schiedam, Zuid-Holland
Country
NETHERLANDSAddress
De Brauwweg 17, , Schiedam, Zuid-Holland, Netherlands
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
RECORDS
The article appears to be a device and the requirements under 518 or to furnish any material or information required by or under section 519 respecting a device were not met.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/11/2003 | 87MOOORTHOPEDIC IMPLANT MATERIAL | 289RECORDS | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Instrumek B.V.'s FDA import refusal history?
Instrumek B.V. (FEI: 3000286413) has 1 FDA import refusal record(s) in our database, spanning from 3/11/2003 to 3/11/2003.
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. Instrumek B.V.'s FEI number is 3000286413.
What types of violations has Instrumek B.V. received?
Instrumek B.V. 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 Instrumek B.V. come from?
All FDA import refusal data for Instrumek B.V. 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.