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

Source: https://www.keypedia.com/records/483/inspire-medical-systems-inc/cc0849cb-8233-4d11-9b8e-e31e154fff6f

> FDA 483 for Inspire Medical Systems Inc. on June 22, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Inspire Medical Systems Inc.
- Inspection Date: 2018-06-22
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Documents

- [483 - 2024-05-10](https://www.keypedia.com/records/483/inspire-medical-systems-inc/91307810-95e3-4c11-8809-dc5bfa6ab003)

## Related Officers

- [investigator](https://www.keypedia.com/people/susan-m-matthias/cd23c465-4411-4988-8676-2089e265622a)

Company: https://www.keypedia.com/companies/inspire-medical-systems-inc/c8cf6ad9-b74a-4b39-83c9-5d6cfbdb4676

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d