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

Source: https://www.globalkeysolutions.net/records/483/loyola-univ-medical-center/bd362a1e-9591-4c5b-b33f-904e03f745f7

> 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: Chicago District Office
- Summary: An FDA inspection of Loyola Univ Medical Center's Hospital Blood Bank in Maywood, IL, revealed two significant observations. The facility failed to maintain concurrent records for manufacturing steps and lacked adequate written standard operating procedures for labeling blood components and completing records. These findings indicate deficiencies in quality control and documentation practices.

## Related Officers

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

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

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