FDA Inspection
Future Diagnostics Solutions B.V.Future Diagnostics Solutions B.V. – FDA Inspection, Jan 19, 2023
Record Details
This FDA Inspection record concerns Future Diagnostics Solutions B.V., with an inspection on January 19, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9c939550-ad25-4dea-8eb3-800ec9c0d48e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1195965
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
8- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate 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 |
|---|---|---|---|
| July 11, 2024 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 1243539 - 2024-07-11
- FDA Inspection 1113204 - 2019-12-12
- FDA Inspection 996828 - 2016-12-08
- FDA Inspection 735964 - 2011-06-17
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