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

An FDA inspection of Expanse Medical Inc. in Pleasanton, CA, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for design validation, with key validation documents remaining in draft form for a device already distributed to patients. Additionally, the company did not properly evaluate complaints for medical device reporting and failed to submit required information for their Class II medical devices to the Global Unique Device Identification Database.