FDA 483 - West TN Regional Blood Center, dba Lifeline Blood Services - April 11, 2019

An FDA inspection of West TN Regional Blood Center, dba Lifeline Blood Services, a blood processing center in Jackson, TN, identified a significant issue regarding equipment calibration. Specifically, equipment used for blood collection and processing was found to be improperly leveled and calibrated, with one device even missing its bubble-level indicator. This indicates a failure to adhere to proper equipment maintenance and operational procedures.