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Abraxis Bioscience LLC's Phoenix drug manufacturing facility violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering its products adulterated. During an FDA inspection in March-April 2022, investigators identified critical failures in investigating batch discrepancies and implementing corrective actions following multiple media fill failures in aseptic processing operations for Abraxane between April and October 2021. The company inadequately assessed root causes of the processing failures and subsequently released potentially affected batches in December 2021 after only one successful media fill run in November 2021, demonstrating insufficient remediation to restore the manufacturing line to a state of control.