# FDA 483 - HSHS St. John's Hospital - September 01, 2022

Source: https://www.globalkeysolutions.net/records/483/hshs-st-johns-hospital/74d01c73-824e-4b6f-9165-d2df8c1b2042

> FDA 483 for HSHS St. John's Hospital on September 01, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HSHS St. John's Hospital
- Inspection Date: 2022-09-01
- Product Type: biologics
- Office Name: Chicago District Office
- Summary: HSHS St. John's Hospital in Springfield, IL, was cited on a Form FDA 483 for failing to adhere to its established procedure for Hepatitis C Virus (HCV) lookback. The hospital did not adequately notify the ordering physician or recipient following a recall notification for a unit of cryoprecipitate confirmed positive for HCV. This lapse in protocol resulted in insufficient attempts and documentation for patient notification regarding potentially infectious blood products.

## Related Officers

- [Esther A. Ofori](https://www.globalkeysolutions.net/people/esther-a-ofori/98108fae-1e09-4849-bceb-18e69dff7ba4)

Company: https://www.globalkeysolutions.net/companies/hshs-st-johns-hospital/5b7d7100-fea0-4d69-b605-1f1e28e424ea

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669