Ascension Saint John Medical CenterMay 9, 2025

FDA 483 - Ascension Saint John Medical Center - May 09, 2025

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Record Details

Ascension Saint John Medical Center in Tulsa, OK, a hospital blood bank, received a Form 483 with two observations. The inspection revealed failures in reviewing records pertinent to irradiated blood products before release and a lack of thorough investigation and documentation of unexplained discrepancies during blood irradiation. These issues indicate deficiencies in quality control and record-keeping practices.

Company: Ascension Saint John Medical Center
Inspection Date: May 9, 2025
Product Type: Biologics
Office: Division of Human and Animal Food Operations - West III
Person: William F. Lagud

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ID · 3fdd7b5c-63c7-471b-93d8-d2bc453668bb