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

Source: https://www.keypedia.com/records/483/ascension-saint-john-medical-center/3fdd7b5c-63c7-471b-93d8-d2bc453668bb

> 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: Division of Human and Animal Food Operations - West III
- Summary: 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.

## Related Documents

- [483 - 2025-05-09](https://www.keypedia.com/records/483/ascension-saint-john-medical-center/9f6a2212-df49-4105-a647-e8b97cc828c9)

## 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/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab