FDA 483 - Savannah Health Services, LLC dba Memorial Health University Medical Center - August 30, 2022

An FDA inspection of Savannah Health Services, LLC dba Memorial Health University Medical Center in Savannah, GA, a blood irradiation facility, identified two observations. The firm failed to adequately validate linear accelerators used for irradiating blood and blood components. Additionally, the standard operating procedures lacked written schedules and procedures for equipment maintenance and calibration.