FDA 483 - LifeSouth Community Blood Centers, Inc. - March 27, 2025

An FDA inspection of LifeSouth Community Blood Centers, Inc. in Dunwoody, GA, revealed three observations related to the collection and processing of blood and blood components. Issues included inadequate preventative maintenance and calibration of equipment, failure to retain essential manufacturing records, and non-adherence to written standard operating procedures for sample collection and temperature monitoring system calibration.