# FDA 483 - Summa Health System - March 21, 2023

Source: https://www.globalkeysolutions.net/records/483/summa-health-system/4e2dd2aa-162c-4f9e-a255-0a94fa033fc6

> FDA 483 for Summa Health System on March 21, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Summa Health System
- Inspection Date: 2023-03-21
- Product Type: biologics
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Summa Health System, a hospital blood bank, identified significant deviations from written standard operating procedures for blood and blood component processing and distribution. The firm failed to ensure physicians signed emergency release forms for uncrossmatched blood and did not consistently follow protocols for monitoring vital signs during transfusions or stopping transfusions when reactions were suspected. These issues indicate a lack of adherence to established procedures, which could impact patient safety.

## Related Officers

- [Nancy L. Neiger](https://www.globalkeysolutions.net/people/nancy-l-neiger/c3209528-eeb3-4a5f-88b1-f503798ed4c5)

Company: https://www.globalkeysolutions.net/companies/summa-health-system/8d7bf562-d4ca-4beb-ad6f-648e9888c0ef

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22