VitalScientific B.V.
✅ Low Risk
FEI: 3001576181 • Spankeren, Gelderland • NETHERLANDS
FEI Number
3001576181
Location
Spankeren, Gelderland
Country
NETHERLANDSAddress
Van Rensselaerweg 4, , Spankeren, Gelderland, Netherlands
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
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).
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 |
|---|---|---|---|
| 12/3/2021 | 83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/13/2011 | 75JJQCOLORIMETER, PHOTOMETER, SPECTROPHOTOMETER FOR CLINICAL USE | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/13/2011 | 75JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE) FOR CLINICAL USE | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is VitalScientific B.V.'s FDA import refusal history?
VitalScientific B.V. (FEI: 3001576181) has 3 FDA import refusal record(s) in our database, spanning from 6/13/2011 to 12/3/2021.
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. VitalScientific B.V.'s FEI number is 3001576181.
What types of violations has VitalScientific B.V. received?
VitalScientific 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 VitalScientific B.V. come from?
All FDA import refusal data for VitalScientific 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.