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

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.