# FDA 483 - Intermountain Medical Center - May 12, 2022

Source: https://www.globalkeysolutions.net/records/483/intermountain-medical-center/a0367721-9895-412c-af85-a47a5e343a0d

> FDA 483 for Intermountain Medical Center on May 12, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Intermountain Medical Center
- Inspection Date: 2022-05-12
- Product Type: biologics
- Office Name: Denver District Office
- Summary: An FDA inspection of Intermountain Medical Center's Transfusion Service in Murray, UT, revealed a critical failure to report a product at fault in causing a transfusion reaction. Specifically, the facility did not notify its blood supplier of positive bacterial contamination in a Red Blood Cell unit that resulted in a patient's transfusion transmitted infection, violating their own standard operating procedures.

## Related Documents

- [145 - 2019-10-25](https://www.globalkeysolutions.net/records/145/intermountain-medical-center/1d6cb314-16a2-472e-975a-fa0a0595c772)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/intermountain-medical-center/0443981c-db7a-4959-bb7f-d780585789cf

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face