# FDA 483 - St. George Regional Hospital - July 20, 2022

Source: https://www.globalkeysolutions.net/records/483/st-george-regional-hospital/8a0968a5-b7c9-46a9-a123-983e5840dd4a

> FDA 483 for St. George Regional Hospital on July 20, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: St. George Regional Hospital
- Inspection Date: 2022-07-20
- Product Type: biologics
- Office Name: Denver District Office
- Summary: An FDA inspection of St. George Regional Hospital's Blood Bank identified significant deficiencies in quality control and record-keeping. The firm failed to thoroughly investigate and document biological product deviations, including instances of incorrect blood product issuance. Additionally, the hospital did not maintain complete records for emergency transfusions, specifically lacking physician signatures and proper justification.

## 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-george-regional-hospital/580618a3-1e89-44c3-9e6a-2e42c86a5cbc

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