# FDA 483 - Freespira, Inc. - April 29, 2022

Source: https://www.globalkeysolutions.net/records/483/freespira-inc/65235739-79ee-4043-b3a9-84cf3af3b967

> FDA 483 for Freespira, Inc. on April 29, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Freespira, Inc.
- Inspection Date: 2022-04-29
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Freespira, Inc. in Kirkland, WA, a medical device manufacturer, was inspected by the FDA from April 27-29, 2022. The inspection revealed significant deficiencies in the firm's quality system, specifically regarding complaint handling, corrective and preventive actions, and equipment maintenance. These issues indicate a lack of adequate procedures and implementation for critical quality processes.

## Related Documents

- [483 - 2025-06-16](https://www.globalkeysolutions.net/records/483/freespira-inc/781a04c5-e14d-4b7b-ac65-819718d790ed)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/christopher-s-genther/e71df42c-9adf-4a78-93e5-c364dcc06b35)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822