FDA 483 - Seniorlife Technologies Inc - February 20, 2026

Seniorlife Technologies Inc. in Bellevue, WA, a medical device manufacturer, was cited for multiple significant deficiencies in its quality management system during an FDA inspection. The observations primarily concern a lack of documented procedures and evidence for critical processes such as unique device identification, design control, process validation, outsourced process control, internal audits, and overall QMS management and document control. These issues indicate a systemic failure to establish and maintain an effective quality system.