Inspire Medical Systems Inc.June 22, 2018

FDA 483 - Inspire Medical Systems Inc. - June 22, 2018

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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.

Company: Inspire Medical Systems Inc.
Inspection Date: June 22, 2018
Product Type: Device
Office: Minneapolis District Office
Person: Susan M. Matthias (investigator)

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ID · cc0849cb-8233-4d11-9b8e-e31e154fff6f