FDA 483 - Suncoast Communities Blood Bank, Inc. - January 31, 2025

An FDA inspection of Suncoast Communities Blood Bank, Inc. in Bradenton, FL, revealed significant deficiencies across four observations. The firm failed to follow written SOPs for donor deferral, exhibited inadequate personnel training for blood collection, and did not thoroughly investigate product discrepancies. Additionally, the inspection found a failure to submit biological product deviation reports within the required 45-day timeframe.