# FDA 483 - Magnolia Medical Technologies, Inc. - July 15, 2021

Source: https://www.keypedia.com/records/483/magnolia-medical-technologies-inc/db719db6-1526-4781-a02c-41f541833d91

> FDA 483 for Magnolia Medical Technologies, Inc. on July 15, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Magnolia Medical Technologies, Inc.
- Inspection Date: 2021-07-15
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Magnolia Medical Technologies, Inc. in Seattle, WA, was inspected and cited for significant deficiencies across its quality system. The inspection revealed inadequate procedures for corrective and preventive actions, design changes, design verification, and production processes. Additionally, the firm failed to adequately investigate device complaints, indicating a systemic breakdown in quality management for its Steripath Gen2 devices.

## Related Documents

- [WARNING_LETTER - 2021-07-15](https://www.keypedia.com/records/warning_letter/magnolia-medical-technologies-inc/0ae342ae-762d-4d1e-a3d0-fdd7d7050fd6)
- [483 - 2025-07-10](https://www.keypedia.com/records/483/magnolia-medical-technologies-inc/08d52361-fc79-4af9-a813-bcffd952a1ed)

## Related Officers

- [Stephen R. Souza](https://www.keypedia.com/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)

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

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