FDA 483 - Philips North America LLC - August 20, 2021

An FDA inspection of Philips North America LLC in Bothell, WA, revealed significant deficiencies in their quality system. The firm failed to submit 19 required supplemental Medical Device Reports (MDRs) in a timely manner. Additionally, procedures for the review and disposition of nonconforming products were not adequately implemented, leading to inaccuracies in quality records, and procedures for equipment maintenance schedules were not established or properly followed.