FDA 483 - American Blood Bank Corp. - August 07, 2019

American Blood Bank Corp. in Miami, FL, a blood bank establishment, was cited for significant deficiencies during an FDA inspection. Observations included failures in donor suitability determination due to pre-populated questionnaires and skipped screening questions, as well as the release of unsuitable blood components (HIV and HCV positive) that were still under quarantine. Additionally, the firm used expired antiseptic solutions for phlebotomy site preparation and failed to obtain required donor contact information.