CGMP Violations at Abraxis Bioscience

A 3/28-4/6 FDA inspection at Abraxis Bioscience, Phoenix, AZ, identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/31 Warning Letter says the specific violation was:

• failing 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.

The letter acknowledges that the firm took significant steps in response to media fill failures but says its response to the form FDA-483 was inadequate. FDA recommends that Abraxis engage a qualified, consultant to assist it in meeting CGMP requirements.

Abraxis was told to correct any violations promptly and to respond was a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.