Future Diagnostics Solutions B.V.
⚠️ Moderate Risk
FEI: 3001857593 • Wijchen, Gelderland • NETHERLANDS
FEI Number
3001857593
Location
Wijchen, Gelderland
Country
NETHERLANDSAddress
Nieuweweg 279, , Wijchen, 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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/4/2025 | 75MMIIMMUNOASSAY METHOD, TROPONIN SUBUNIT | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 12/29/2017 | 80FRCINDICATOR, BIOLOGICAL STERILIZATION PROCESS | Division of Southeast Imports (DSEI) | |
| 6/6/2016 | 81MVUREAGENTS, SPECIFIC, ANALYTE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Future Diagnostics Solutions B.V.'s FDA import refusal history?
Future Diagnostics Solutions B.V. (FEI: 3001857593) has 3 FDA import refusal record(s) in our database, spanning from 6/6/2016 to 3/4/2025.
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. Future Diagnostics Solutions B.V.'s FEI number is 3001857593.
What types of violations has Future Diagnostics Solutions B.V. received?
Future Diagnostics Solutions B.V. has been cited for 4 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 Future Diagnostics Solutions B.V. come from?
All FDA import refusal data for Future Diagnostics Solutions 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.