# FDA 483 - Rush University Medical Center Blood Center - June 20, 2008

Source: https://www.globalkeysolutions.net/records/483/rush-university-medical-center-blood-center/c6a2f6f4-58d8-4afe-9346-d9fadba5c0bb

> FDA 483 for Rush University Medical Center Blood Center on June 20, 2008. 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: 2008-06-20
- Product Type: biologics
- Office Name: Chicago District Office
- Summary: An FDA inspection of Rush University Medical Center Blood Center in Chicago, IL, revealed two significant observations. The facility failed to submit multiple biological product deviation reports within the required 45-day timeframe. Additionally, the blood center did not perform thorough investigations or maintain adequate records for unexplained discrepancies, including instances of blood product mistyping.

## Related Documents

- [483 - 2017-02-21](https://www.globalkeysolutions.net/records/483/rush-university-medical-center-blood-center/6e398408-dd55-484d-bd92-70d958297df2)
- [483 - 2019-03-08](https://www.globalkeysolutions.net/records/483/rush-university-medical-center-blood-center/c0953d13-faf7-4c86-99ad-0a725c872e70)

## Related Officers

- [Quality Program Specialist/Program Analyst](https://www.globalkeysolutions.net/people/lequita-mayhew/7c553294-3678-4771-acb4-92c4b8fbc0b1)

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