FDA 483 - Expanse Medical Inc. - January 15, 2026

Expanse Medical Inc. in Pleasanton, CA, a medical device manufacturer, received a Form FDA 483 with three observations during an inspection from January 9-15, 2026. The inspection revealed significant deficiencies in design validation procedures, inadequate complaint handling processes, and a failure to submit required device information to the Global Unique Device Identification Database for their (b)(4) System. These issues indicate a lack of robust quality system controls for their Class II medical device.