FDA 483 - Philips North America LLC - October 27, 2022

An FDA inspection of Philips North America LLC in Bothell, WA, revealed significant deficiencies in their quality system. The firm failed to timely submit Medical Device Reports for device malfunctions and lacked an effective system for identifying and evaluating reportable events. Additionally, procedures for corrective and preventive actions were found to be inadequately established, leading to missed deadlines and incomplete investigations.