FDA 483 - Abraxis Bioscience, LLC - February 19, 2020

Abraxis Bioscience, LLC, a sterile drug manufacturer in Phoenix, AZ, received a Form 483 with four observations related to significant quality system deficiencies. The inspection revealed issues with personnel training for aseptic processes, inadequate computer system controls allowing unauthorized data manipulation, incomplete investigation records for deviations and CAPAs, and widespread failures in good documentation practices including late entries and unrecorded deviations. These findings indicate a need for comprehensive improvements in the firm's quality management system.