Company
NetherlandsFuture Diagnostics Solutions B.V., Wijchen, Netherlands – FDA Inspections
Inspection records and compliance data for Future Diagnostics Solutions B.V. in Wijchen. 5 FDA inspections on record (2 OAI), 1 Form 483, 1 warning letter, last inspected July 11, 2024.
Company Profile
This profile covers Future Diagnostics Solutions B.V. based in Wijchen, Netherlands.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 2
- VAI
- 2
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected June 17, 2011. Last inspected July 11, 2024.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Lack of or inadequate procedures2 inspections
- Quality audits - Lack of or inadequate procedures2 inspections
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 11, 2024 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1243539 |
| January 19, 2023 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1195965 |
| December 12, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1113204 |
| December 8, 2016 | Not classified | Medical Devices & Rad Health | 996828 |
| June 17, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 735964 |
FDA documents
Form 483s (1)
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Future Diagnostics Solutions B.V.
FEI Number
3001857593
Address
Nieuweweg 279, Wijchen, Netherlands
Country
Netherlands
ID: 6dec2eda-03d3-4e3d-968d-92eb968caf48