Magnolia Medical Technologies, Inc.July 15, 2021

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

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Record Details

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.

Company: Magnolia Medical Technologies, Inc.
Inspection Date: July 15, 2021
Product Type: Device
Office: Division of Human and Animal Food Operations - West VI
Person: Stephen R. Souza

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