FDA Inspection
Future Diagnostics Solutions B.V.Future Diagnostics Solutions B.V. – FDA Inspection, Dec 12, 2019
Record Details
This FDA Inspection record concerns Future Diagnostics Solutions B.V., with an inspection on December 12, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 12, 2019
- Product Type
- Devices
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ID · 745d3633-9516-4040-9d13-a26993e72450
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1113204
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(e)Design review - documentation
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 |
|---|---|---|---|
| July 11, 2024 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 19, 2023 | OAI | 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 1243539 - 2024-07-11
- FDA Inspection 1195965 - 2023-01-19
- FDA Inspection 996828 - 2016-12-08
- FDA Inspection 735964 - 2011-06-17
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