Abraxis Bioscience LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

Passage 2

You failed to effectively implement corrective actions and preventive actions (CAPA) and return your aseptic processing line and manufacturing operations to a state of control. Multiple media fill failures occurred between April and October 2021, when simulating aseptic processing operations on the filling line used for your drug product Abraxane (a sterile **(b)(4)** drug).

Passage 3

Your firm failed to perform a sufficiently comprehensive evaluation and remediation upon this loss of state of control in your aseptic operations. In December 2021, you released batches potentially impacted by these failures following **(b)(4)** successful media fill run (conducted in November 2021).

Passage 4

Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.