FDA 483 - Magnolia Medical Technologies, Inc. - July 10, 2025
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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.
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- Seattle District Office
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ID · 08d52361-fc79-4af9-a813-bcffd952a1ed