FDA 483 - Parkview Health Laboratories - January 30, 2025
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An FDA inspection of Parkview Health Laboratories' Hospital Blood Bank in Fort Wayne, IN, revealed a significant deficiency in record-keeping for emergency transfusions. The facility failed to maintain records, including physician signatures, for numerous emergency and massive transfusion events, instead documenting verbal consents or nurse signatures. This indicates a serious lapse in ensuring proper authorization and documentation for critical blood product releases.
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- Detroit District Office
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ID · 533726a4-a14c-4a3b-9f2a-1a0d9d31c770