# FDA 483 - Rush University Medical Center Blood Center - March 08, 2019

Source: https://www.globalkeysolutions.net/records/483/rush-university-medical-center-blood-center/c0953d13-faf7-4c86-99ad-0a725c872e70

> FDA 483 for Rush University Medical Center Blood Center on March 08, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rush University Medical Center Blood Center
- Inspection Date: 2019-03-08
- Product Type: biologics
- Office Name: Chicago District Office
- Summary: The FDA inspected Rush University Medical Center Blood Center in Chicago, IL, and issued a Form 483 citing three observations related to quality control and record-keeping. Deficiencies included inadequate approval processes for written procedures and equipment requalification, insufficient documentation for emergency transfusions, and late submission of biological product deviation reports. These findings highlight significant issues in the firm's adherence to regulatory and procedural requirements for blood bank operations.

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## Related Officers

- [Uruaku A Obasi](https://www.globalkeysolutions.net/people/uruaku-a-obasi/8ff0e6f4-da89-4ec0-86f4-7ebf8cf529b8)

Company: https://www.globalkeysolutions.net/companies/rush-university-medical-center-blood-center/2819bc18-3b8e-487a-badc-0d5b611df1c3

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