Warning letter
Future Diagnostics Solutions B.V.: warning letter of May 11, 2023
FDA warning letter 653493 · Center for Devices and Radiological Health
Key facts
| Reference number | 653493 |
|---|---|
| Company | Future Diagnostics Solutions B.V. |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | May 11, 2023 |
| Posted date | Apr 30, 2024 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 803.3, 803.12(a), 803, 803.17(a)(2), 803.17(a)(1), 803.50(a), 820, 803.50(a)(2), 803.17(a)(3), 803.17(a) |
| Inspection city | Wijchen |
| Inspection start date | Jan 16, 2023 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
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About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: