FDA 483 - Philips North America LLC - August 20, 2021
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · fcb0be72-f60b-4b74-be4e-58b92ed403af