FDA 483 - Abraxis Bioscience, LLC - April 06, 2022

An FDA inspection of Abraxis Bioscience, LLC in Phoenix, AZ, revealed significant deficiencies in their quality system and aseptic processing. The firm failed to thoroughly investigate media fill failures and released drug product manufactured under processes that were not adequately evaluated. Additionally, procedures to prevent microbiological contamination of sterile drug products were not properly established or followed, particularly concerning personnel sampling during aseptic operations.