# FDA 483 - Freespira, Inc. - June 16, 2025

Source: https://www.globalkeysolutions.net/records/483/freespira-inc/781a04c5-e14d-4b7b-ac65-819718d790ed

> FDA 483 for Freespira, Inc. on June 16, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Freespira, Inc.
- Inspection Date: 2025-06-16
- Product Type: device
- Office Name: Seattle District Office
- Summary: Freespira, Inc. in Kirkland, WA, a medical device manufacturer, was cited for three significant quality system deficiencies during an FDA inspection. Observations included inadequate procedures for corrective and preventive actions, failures in complaint handling, and insufficient controls for purchasing and supplier evaluation. These issues indicate a need for comprehensive improvements in their quality management system.

## Related Documents

- [483 - 2022-04-29](https://www.globalkeysolutions.net/records/483/freespira-inc/65235739-79ee-4043-b3a9-84cf3af3b967)

## Related Officers

- [Brian R. Hendricks](https://www.globalkeysolutions.net/people/brian-r-hendricks/c2759597-935c-4b48-8fc8-2d1443098cc1)

Company: https://www.globalkeysolutions.net/companies/freespira-inc/fbc92636-642c-4206-ab35-ff9f04f70dc3

Office: https://www.globalkeysolutions.net/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913