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

An FDA inspection conducted on August 29-30, 2022, at Savannah Health Services, LLC, operating as Memorial Health University Medical Center in Savannah, GA, identified two significant observations related to their blood irradiation processes. The facility, inspected as a Blood Irradiation (Hospital) establishment, received an FDA Form 483 report outlining these deficiencies. The primary issue was the firm's 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 (serial numbers (b) (4) and (b) (4)) used for irradiating blood and blood components. This impacted approximately (b) (4) blood and blood components irradiated between 2018 and 2021. The second observation highlighted that the standard operating procedures lacked written descriptions of schedules and procedures for equipment maintenance and calibration, particularly concerning the linear accelerators used for blood and blood components. These observations indicate non-compliance with regulatory requirements under the Federal Food, Drug, and Cosmetic Act. While the FDA 483 report itself does not mandate specific actions, it signals that the firm is expected to address these conditions through corrective actions, which can be discussed with the FDA or submitted for review. Addressing these deficiencies is crucial to ensure the safety and quality of irradiated blood products.