# FDA 483 - Rush University Medical Center Blood Center - February 21, 2017

Source: https://www.keypedia.com/records/483/rush-university-medical-center-blood-center/6e398408-dd55-484d-bd92-70d958297df2

> FDA 483 for Rush University Medical Center Blood Center on February 21, 2017. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Rush University Medical Center Blood Center
- Inspection Date: 2017-02-21
- Product Type: biologics
- Office Name: Chicago District Office
- Summary: An FDA inspection of Rush University Medical Center Blood Center 262 Jelke in Chicago, IL, identified significant compliance issues. The facility failed to report numerous biological product deviations within the required 45-day timeframe and was found to have missing biological product deviation records. Additionally, the inspection revealed a lack of official training for the Quality Assurance Coordinator responsible for verifying, documenting, and submitting these critical reports.

## Related Documents

- [483 - 2008-06-20](https://www.keypedia.com/records/483/rush-university-medical-center-blood-center/c6a2f6f4-58d8-4afe-9346-d9fadba5c0bb)
- [483 - 2019-03-08](https://www.keypedia.com/records/483/rush-university-medical-center-blood-center/c0953d13-faf7-4c86-99ad-0a725c872e70)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/adam-j-taylor/a6e86ebd-4079-4c56-9129-8574e42ef75c)
- [investigator](https://www.keypedia.com/people/brantley-s-collins/c806aac1-3d89-4427-8aeb-6d9db6dfc2f4)

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

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