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

Savannah Health Services, LLC, operating as Memorial Health University Medical Center, received an FDA Form 483 following an inspection conducted from August 29-30, 2022. The inspection of their blood irradiation establishment identified two significant observations related to their blood and blood component irradiation processes.The first observation cited a failure to establish adequate provisions for monitoring the reliability, accuracy, precision, and performance of laboratory test procedures and instruments. Specifically, the firm did not validate two linear accelerators used for irradiating blood and blood components, which had been utilized for numerous blood and blood component irradiations from 2018 through 2021.The second observation highlighted that the standard operating procedures lacked a written description of schedules and procedures for equipment maintenance and calibration, particularly for the linear accelerators employed in blood and blood component irradiation.The issuance of an FDA Form 483 indicates that the FDA observed conditions or practices requiring attention. Memorial Health University Medical Center is expected to promptly address these findings and implement comprehensive corrective actions to resolve the identified deficiencies.