483
Inspire Medical Systems Inc.Inspire Medical Systems Inc. – FDA 483, Jun 22, 2018
Record Details
An FDA inspection of Inspire Medical Systems Inc. in Maple Grove, MN, revealed significant compliance issues. The firm failed to submit numerous Medical Device Reports (MDRs) within the required 30-day timeframe. Additionally, the inspection found inadequate documentation of corrective and preventive action (CAPA) activities, particularly concerning supplier CAPAs.
View Company Profile
ID · cc0849cb-8233-4d11-9b8e-e31e154fff6f
Other documents for Inspire Medical Systems Inc.
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.