FDA 483 - Philips North America - December 13, 2023

An FDA inspection of Philips North America in Cambridge, MA, revealed significant deficiencies in their quality system, particularly concerning the Vital Plus Patient Monitoring System. The firm's procedures for complaint handling, corrective and preventive actions (CAPA), and control of nonconforming products were found to be inadequately established. These issues included missing documentation, unapproved extensions, and lack of adherence to internal procedural requirements.