Inspire Medical Systems Inc. – FDA EIR, Apr 29, 2015

An FDA inspection of Inspire Medical Systems Inc. was conducted from April 28-29, 2015, focusing on their Inspire II Upper Airway Stimulation System. This post-market approval (PMA) inspection, guided by Compliance Program 7383.001, evaluated manufacturing and design changes, quality data, and the CAPA system for their device, which treats obstructive sleep apnea. The inspection also covered a PMA supplement for physician programmer updates and a field action concerning a missing patient remote label. While no formal FDA-483 (Inspectional Observations) was issued to Inspire Medical Systems Inc., signifying no significant regulatory violations, one verbal observation noted the absence of a nonconformance initiation for nine incoming telemetry modules that failed acceptance criteria. A concurrent inspection at a contract manufacturer for the device's leads also yielded verbal observations regarding insufficient annual risk assessments for critical suppliers, undocumented medical adhesive cure times, and management review attendees. Ultimately, the FDA's final district decision for Inspire Medical Systems was "No Action Indicated," meaning no formal regulatory actions were required.