FDA 483 - Philips North America LLC - November 06, 2024

An FDA inspection of Philips North America LLC in Bothell, WA, revealed significant quality system deficiencies. The firm was cited for inadequate documentation of corrective and preventive action activities, particularly concerning risk assessments for late regulatory reporting and delayed complaint processing, which was a repeat observation. Additionally, device history records for HeartStart HS1 and FRx Defibrillators were found to be incomplete, lacking required labeling information.