FDA 483 - Xhale Assurance, Inc. - April 05, 2019

Xhale Assurance, Inc. in Gainesville, FL, received a Form FDA-483 following an inspection that revealed significant deficiencies across multiple quality system areas. The firm's Alar SpO2 sensors were central to issues including inadequate corrective and preventive actions, failures in medical device reporting, and insufficient supplier controls. Additionally, procedures for design change and complaint handling were found to be poorly established.