FDA 483 - ABO Holdings Inc

ABO Holdings, Inc. in San Diego, California, a plasmapheresis center, was cited for two significant issues during an FDA inspection. The firm failed to correctly perform Performance Qualification studies for centrifuges used in donor qualification by selecting incorrect assay values. Additionally, the firm did not test subsequent donations for relevant transfusion transmitted infections (RTTI) when a donor previously tested reactive, leading to samples not being shipped to the contract testing laboratory.