FDA 483 - ABO Holdings Inc

ABO Holdings, Inc., a plasmapheresis center in Calexico, California, was cited for failing to provide essential information to donors deferred due to reactive screening test results for Relevant Transfusion-Transmitted Infections (RTTI). This includes not informing donors about their deferral status, the types of donations they should no longer make, and the specific RTTI test results that led to their deferral. This lapse in donor notification is a significant compliance issue impacting donor safety and public health.