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

Continental Services Group, Inc., a blood bank based in Ft Lauderdale, FL, underwent an FDA inspection from July 22-24, 2024. The inspection revealed two significant observations regarding their operational practices. The first observation, a repeat finding from a previous inspection in August 2022, noted a failure to adequately maintain donor and general records. Specifically, the "Web Software (version 3.3)" used for donor screening and eligibility determination, implemented since August 2022, had not been properly validated. This indicates a lapse in ensuring the reliability of critical data. The second observation concerned the improper storage of supplies. Investigators found various Vacuette and Vacutainer blood collection tubes stored outside the manufacturers' recommended temperature ranges, potentially compromising their quality and integrity. These findings indicate deviations from the Federal Food, Drug, and Cosmetic Act and related regulations for blood bank operations. Although the FDA 483 report does not prescribe specific actions, Continental Services Group, Inc. is expected to promptly implement comprehensive corrective actions to address these deficiencies, ensure ongoing compliance, and uphold the quality and safety of their blood components.