# FDA 483 - Magnolia Medical Technologies, Inc. - July 10, 2025

Source: https://www.keypedia.com/records/483/magnolia-medical-technologies-inc/08d52361-fc79-4af9-a813-bcffd952a1ed

> FDA 483 for Magnolia Medical Technologies, Inc. on July 10, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Magnolia Medical Technologies, Inc.
- Inspection Date: 2025-07-10
- Product Type: device
- Office Name: Seattle District Office
- Summary: Magnolia Medical Technologies, Inc. in Seattle, WA, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to investigate multiple adverse events related to its Steripath Blood Collection System and did not submit required Medical Device Reports. Additionally, the company did not adequately follow its own procedures for corrective and preventive actions, with several CAPAs exceeding their due dates without proper extension documentation.

## Related Documents

- [483 - 2021-07-15](https://www.keypedia.com/records/483/magnolia-medical-technologies-inc/db719db6-1526-4781-a02c-41f541833d91)
- [WARNING_LETTER - 2021-07-15](https://www.keypedia.com/records/warning_letter/magnolia-medical-technologies-inc/0ae342ae-762d-4d1e-a3d0-fdd7d7050fd6)

## Related Officers

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

Company: https://www.keypedia.com/companies/magnolia-medical-technologies-inc/91da9da6-9fc1-498e-a676-e6c01ca5ed2e

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