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

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.