FDA 483 - LifeSouth Community Blood Centers, Inc. - August 18, 2025

LifeSouth Community Blood Centers, Inc. in Gainesville, FL, was inspected by the FDA from August 12-18, 2025. The inspection revealed a significant issue related to the proper use and documentation of ABO blood grouping reagents. The firm failed to perform quality control testing and document storage temperatures according to manufacturer instructions and federal regulations, indicating a lapse in critical blood product handling procedures.