FDA 483 - ABO Holdings, Inc. - November 21, 2024

ABO Holdings, Inc., a plasmapheresis center in San Diego, California, was inspected by the FDA from November 19-21, 2024. The inspection revealed two significant issues regarding compliance with regulatory requirements for blood and blood component manufacturing. Firstly, the firm incorrectly performed Performance Qualification studies for its centrifuges, critical for donor qualification. They used incorrect assay values from the manufacturer's instructions, leading to inaccurate acceptable ranges for reference control materials. This directly impacts the ability to demonstrate instruments perform as intended and meet Source Plasma manufacturing requirements. Secondly, the company failed to consistently test all donations for relevant transfusion-transmitted infections (RTTI). Specifically, subsequent donations collected after a donor initially tested reactive for an RTTI, but before their permanent deferral, were not shipped to the testing laboratory, and testing orders were cancelled. Federal regulations require blood establishments collecting blood and blood components for further manufacturing to test each donation for RTTI. ABO Holdings, Inc. must address these observations by implementing corrective actions to achieve full compliance with FDA regulations.