FDA 483 - Abraxis Bioscience, LLC - October 06, 2023

Abraxis Bioscience, LLC, a sterile drug manufacturer in Phoenix, AZ, was cited with six observations during an FDA inspection from September 25 to October 6, 2023. The inspection revealed significant deficiencies across quality systems, including inadequate data integrity controls, incomplete investigations into out-of-specification results, and failures in maintaining aseptic processing equipment. Additional concerns involved insufficient secondary verification of laboratory records and poor management of reserve sample evaluations.