FDA Inspection
Future Diagnostics Solutions B.V.Future Diagnostics Solutions B.V. – FDA Inspection, Jul 11, 2024
Record Details
This FDA Inspection record concerns Future Diagnostics Solutions B.V., with an inspection on July 11, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e25ce6d8-bb60-4d5d-84fc-55efbb179672
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1243539
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.250(b)Sampling plans
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Future Diagnostics Solutions B.V.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 19, 2023 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 12, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 8, 2016 | Not classified | Office of Inspections and Investigations | |
| June 17, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Future Diagnostics Solutions B.V.
- FDA Inspection 1195965 - 2023-01-19
- FDA Inspection 1113204 - 2019-12-12
- FDA Inspection 996828 - 2016-12-08
- FDA Inspection 735964 - 2011-06-17
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