# FDA 483 - Seniorlife Technologies Inc - March 26, 2025

Source: https://www.keypedia.com/records/483/seniorlife-technologies-inc/9030a59c-8655-41ec-a3ba-d27e4e103644

> FDA 483 for Seniorlife Technologies Inc on March 26, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Seniorlife Technologies Inc
- Inspection Date: 2025-03-26
- Product Type: device
- Office Name: Seattle District Office
- Summary: An FDA inspection of Seniorlife Technologies Inc. in Bellevue, WA, a manufacturer of a Class II Software as a Medical Device (SaMD), revealed significant deficiencies across its quality system. The firm lacked established written procedures for critical areas including Medical Device Reporting, design control, corrective and preventive actions, complaint handling, training, and quality audits. Additionally, no management representative had been appointed to oversee the quality system, indicating a fundamental absence of essential quality management processes.

## Related Officers

- [Brian R. Hendricks](https://www.keypedia.com/people/brian-r-hendricks/c2759597-935c-4b48-8fc8-2d1443098cc1)

Company: https://www.keypedia.com/companies/seniorlife-technologies-inc/36c319e0-21ad-4534-b86b-5571103688b6

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913