# FDA 483 - GE Healthcare Finland Oy - May 16, 2024

Source: https://www.keypedia.com/records/483/ge-healthcare-finland-oy/d2d9aa31-532d-4a6e-8aee-be914775b00e

> FDA 483 for GE Healthcare Finland Oy on May 16, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: GE Healthcare Finland Oy
- Inspection Date: 2024-05-16
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: GE Healthcare Finland Oy, a medical device manufacturer in Helsinki, Finland, was cited with four observations during an FDA inspection. The inspection revealed significant deficiencies in the design control processes for their TruSignal SpO2 sensors, including inadequate design verification, incorrect translation of design into production specifications, and insufficient documentation of design outputs. Additionally, the firm's sampling plans for electrical safety verification lacked valid statistical rationale.

## Related Officers

- [Investigator at US Food and Drug Administration](https://www.keypedia.com/people/brian-s-keefer/4fec578b-ca72-4d79-8634-3a9fe7ecd9a5)

Company: https://www.keypedia.com/companies/ge-healthcare-finland-oy/a7f09baa-95cf-49ee-aade-4e9631acc895

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