# FDA 483 - Future Diagnostics Solutions B.V. - January 19, 2023

Source: https://www.keypedia.com/records/483/future-diagnostics-solutions-bv/d44a5d13-5961-48fb-a12e-ca97e8711110

> FDA 483 for Future Diagnostics Solutions B.V. on January 19, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Future Diagnostics Solutions B.V.
- Inspection Date: 2023-01-19
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Future Diagnostics Solutions B.V. in Wijchen, Netherlands, was cited with four observations during an FDA inspection. The firm failed to submit Medical Device Reports (MDRs) for device malfunctions and lacked statistically valid sampling plans. Additionally, procedures for quality audits and corrective and preventive actions were not adequately established, indicating significant quality system deficiencies.

## Related Documents

- [WARNING_LETTER - 2023-01-19](https://www.keypedia.com/records/warning_letter/future-diagnostics-solutions-bv/624ca771-eedd-436a-a0b3-c422eed1e813)

## Related Officers

- [Sara M. Onyango](https://www.keypedia.com/people/sara-m-onyango/643c6ad3-9747-4bc2-9e8e-72f97b11e659)

Company: https://www.keypedia.com/companies/future-diagnostics-solutions-bv/6dec2eda-03d3-4e3d-968d-92eb968caf48

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd