# FDA 483 - St Luke's Regional Medical Center - May 04, 2023

Source: https://www.globalkeysolutions.net/records/483/st-lukes-regional-medical-center/5eff9746-277c-4b32-a37b-0b50474b4ea8

> FDA 483 for St Luke's 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: St Luke's 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 St Luke's Regional Medical Center, a blood bank in Boise, ID, revealed significant deficiencies in their quality control unit, standard operating procedures, and record-keeping. The firm lacked written procedures for quality control responsibilities, investigating product deviations, and handling mislabeled blood products. Additionally, the facility failed to maintain proper records for transfusion reaction reports and complaints.

## Related Officers

- [Emily B. Camire](https://www.globalkeysolutions.net/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)

Company: https://www.globalkeysolutions.net/companies/st-lukes-regional-medical-center/c4b0a08a-0ccc-4e8c-9d3b-b747b2af273b

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