FDA 483 - Apneicare LLC dba Patient Safety Inc. - August 23, 2022

An FDA inspection of Apneacare LLC dba Patient Safety Inc. in Columbus, OH, a medical device manufacturer, revealed significant deficiencies in its quality system. The firm's procedures for complaint handling, corrective and preventive actions, and design change control were found to be inadequately established. These recurring observations indicate systemic issues with documentation, verification, and consistent implementation of critical quality processes.