# FDA 483 - Northwestern Medicine Central DuPage Hospital - February 22, 2019

Source: https://www.globalkeysolutions.net/records/483/northwestern-medicine-central-dupage-hospital/1dd5c75d-a712-4d20-a90c-eaa6449bed28

> FDA 483 for Northwestern Medicine Central DuPage Hospital on February 22, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Northwestern Medicine Central DuPage Hospital
- Inspection Date: 2019-02-22
- Product Type: biologics
- Office Name: Chicago District Office
- Summary: An FDA inspection of Northwestern Medicine Central DuPage Hospital in Winfield, IL, identified significant issues in their HCT/P testing laboratory and blood bank operations. The firm failed to follow manufacturer instructions for communicable disease testing, did not retain records for the required duration, and lacked a robust quality program to properly investigate and document deviations. These observations indicate a failure to adhere to core CGTP requirements and maintain adequate quality control processes.

## Related Officers

- [Travis S. Bradley](https://www.globalkeysolutions.net/people/travis-s-bradley/4d7756cb-65fd-4bd6-be24-25710668e6d8)
- [issuing_officer](https://www.globalkeysolutions.net/people/adam-j-taylor/a6e86ebd-4079-4c56-9129-8574e42ef75c)

Company: https://www.globalkeysolutions.net/companies/northwestern-medicine-central-dupage-hospital/d04451ef-7604-49a5-8df5-97b5adb87b96

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