FDA 483 - Philips North America LLC - March 25, 2020

Philips North America LLC in Bothell, WA, a medical device manufacturer, was cited for inadequate corrective and preventive action (CAPA) procedures. The firm failed to adequately establish procedures for CAPA, resulting in numerous Class 3 defibrillators being missed from Field Change Orders (FCOs) despite a Health Hazard Evaluation identifying a serious risk of injury or permanent impairment. The investigation into affected devices was significantly delayed, taking 355 days to identify all at-risk devices after determining a new FCO was required.