Spierings Orthopaedics B.V.
⚠️ Moderate Risk
FEI: 3002736229 • Nijmegen, Gelderland • NETHERLANDS
FEI Number
3002736229
Location
Nijmegen, Gelderland
Country
NETHERLANDSAddress
Madoerastraat 24, , Nijmegen, Gelderland, 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
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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).
Refusal History
Frequently Asked Questions
What is Spierings Orthopaedics B.V.'s FDA import refusal history?
Spierings Orthopaedics B.V. (FEI: 3002736229) has 2 FDA import refusal record(s) in our database, spanning from 10/15/2001 to 10/2/2024.
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. Spierings Orthopaedics B.V.'s FEI number is 3002736229.
What types of violations has Spierings Orthopaedics B.V. received?
Spierings Orthopaedics B.V. 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 Spierings Orthopaedics B.V. come from?
All FDA import refusal data for Spierings Orthopaedics 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.