FDA 483 - Philips Ultrasound, Inc. - January 31, 2025

Philips Ultrasound, LLC received a Form 483 citing significant deficiencies in its quality system. The firm failed to adequately review and investigate complaints, particularly those related to MDR reportable events, and maintained incomplete complaint files. Additionally, the company's corrective and preventive action procedures were not effectively established or implemented, and there were critical gaps in supplier quality management for outsourced complaint handling and medical device reporting.