# FDA 483 - Saint Alphonsus Regional Medical Center - May 04, 2023

Source: https://www.keypedia.com/records/483/saint-alphonsus-regional-medical-center/f5b65b7c-7a68-4a31-a373-976aa8383090

> FDA 483 for Saint Alphonsus Regional Medical Center on May 04, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Saint Alphonsus Regional Medical Center
- Inspection Date: 2023-05-04
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: An FDA inspection of Saint Alphonsus Regional Medical Center in Boise, ID, a hospital blood bank, identified two significant observations. The facility failed to report the issuance of two expired units of Red Blood Cells. Additionally, their standard operating procedures for compatibility testing lacked adequate provisions for expediting transfusions in emergencies, as evidenced by numerous unsigned emergency release slips.

## Related Officers

- [Garrad R. Poole](https://www.keypedia.com/people/garrad-r-poole/7fc97953-367e-459b-905d-25efe6ec39d2)

Company: https://www.keypedia.com/companies/saint-alphonsus-regional-medical-center/917ab086-4996-4cb6-80fd-1669cea74794

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822