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

Source: https://www.keypedia.com/records/483/ascension-saint-john-medical-center/9f6a2212-df49-4105-a647-e8b97cc828c9

> FDA 483 for Ascension Saint John Medical Center on May 09, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ascension Saint John Medical Center
- Inspection Date: 2025-05-09
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: 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.

## Related Officers

- [William F. Lagud](https://www.keypedia.com/people/william-f-lagud/c90c4bd6-bb56-4a60-a5f8-cbc648bb8dbe)

Company: https://www.keypedia.com/companies/ascension-saint-john-medical-center/4ce50bad-a166-493a-9521-2a91e70de1c0

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9