483
Ascension Saint John Medical CenterFDA 483 - Ascension Saint John Medical Center - May 09, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
Ascension Saint John Medical Center in Tulsa, OK, a hospital blood bank, received two observations during an FDA inspection. The firm failed to review records pertinent to the release of irradiated blood and blood components. Additionally, the firm did not thoroughly investigate and document unexplained discrepancies and status alarms observed during the irradiation process.
- Office
- Dallas District Office
- Person
Open in Dashboard
ID · 9f6a2212-df49-4105-a647-e8b97cc828c9