FDA 483 - Philips North America LLC - November 03, 2023

Philips North America LLC, a manufacturer of automated external defibrillators (AEDs) in Bothell, WA, was cited for significant deficiencies in its quality system. The inspection revealed inadequate procedures for corrective and preventive actions (CAPA), specifically concerning recurring beeper failures in HeartStart HS1 and FRx AEDs. Additionally, the firm failed to adequately establish procedures for receiving, reviewing, and evaluating complaints, leading to incomplete documentation of device issues.