# FDA 483 - Loyola Univ Medical Center - December 05, 2024

Source: https://www.keypedia.com/records/483/loyola-univ-medical-center/4fa823d5-5a06-4e3c-b72b-636692e297fc

> FDA 483 for Loyola Univ Medical Center on December 05, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Loyola Univ Medical Center
- Inspection Date: 2024-12-05
- Product Type: biologics
- Office Name: FDA District Office — Chicago, Illinois
- Summary: Loyola Univ Medical Center in Maywood, IL, a hospital blood bank, was inspected by the FDA from December 3-5, 2024. The inspection revealed issues with concurrent record-keeping during product manufacturing and a lack of established written standard operating procedures for processing blood and blood components. These observations indicate deficiencies in quality system controls related to documentation and procedural adherence.

## Related Documents

- [483 - 2024-12-05](https://www.keypedia.com/records/483/loyola-univ-medical-center/bd362a1e-9591-4c5b-b33f-904e03f745f7)

## Related Officers

- [Gabryelle J. Solverud](https://www.keypedia.com/people/gabryelle-j-solverud/29c4452f-2f7a-4325-8f8d-7046fcb4690f)

Company: https://www.keypedia.com/companies/loyola-univ-medical-center/e2f3c4fb-ff88-44f5-b038-d0cfbf05820b

Office: https://www.keypedia.com/offices/fda-district-office-chicago-illinois/62c2811c-10c5-4d74-99d0-eb5047ef3b65