FDA 483 - LifeSouth Community Blood Centers, Inc - July 24, 2018

Lifesouth Community Blood Centers, Inc. in Gainesville, FL, a cord blood manufacturer, was cited for significant deficiencies across its quality system during an FDA inspection. Observations included a repeat finding for inadequate reserve samples, failures in deviation reporting and investigation, lack of Quality Control Unit authority and written procedures, and poor computer system controls. The firm also had issues with environmental monitoring, laboratory controls for media growth promotion, aseptic cleaning, and product labeling.