# FDA 483 - INSPIRE MEDICAL SYSTEMS INC - December 19, 2025

Source: https://www.keypedia.com/records/483/inspire-medical-systems-inc/af498cf7-b447-4e40-9bc0-786b43125c85

> FDA 483 for INSPIRE MEDICAL SYSTEMS INC on December 19, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: INSPIRE MEDICAL SYSTEMS INC
- Inspection Date: 2025-12-19
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of INSPIRE MEDICAL SYSTEMS INC in Golden Valley, MN, revealed significant deficiencies in their complaint handling system. The firm failed to adequately establish and implement procedures for receiving, reviewing, and evaluating complaints, particularly regarding Medical Device Reporting (MDR) rationale for patient deaths. Additionally, complaint investigations for patient deaths lacked adequate documentation, and complaints were not processed uniformly or in a timely manner.

## Related Officers

- [Alicia U. Jacobo](https://www.keypedia.com/people/alicia-u-jacobo/5f75a995-c0df-4615-be88-d401df48ad26)

Company: https://www.keypedia.com/companies/inspire-medical-systems-inc/5ce67892-724b-48fd-be65-864674b95010

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