FDA 483 - Continental Services Group, Inc. - July 24, 2024

Continental Services Group, Inc. in Ft Lauderdale, FL, a blood bank, was cited with two observations during an FDA inspection from July 22-24, 2024. The inspection revealed issues with maintaining donor and general records, specifically regarding unvalidated software used for donor screening. Additionally, critical blood collection supplies were found stored outside of manufacturer-recommended temperature ranges.